| Primary | Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups | Percent change from baseline to week (wk) 48 in DXA-measured BMD at the spine for the randomized study groups. Lumbar spine BMD (L1 - L4) (g/cm2) change from Baseline to wk 48 visit. | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be greater than the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.19(-1.54 to 1.48)
- OG0010.09(-1.49 to 2.61)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Wilcoxon (Mann-Whitney) | | 0.1166 | P-value from Wilcoxon rank sum test for change between baseline and Week 48 Vitamin D vs. Placebo | | | | | | | | | | | | | Other | | |
|
| Secondary | Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be greater than the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups | The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | z-score | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups | The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | z-score | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups | The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | z-score | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups | The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | z-score | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent change | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups | The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | z-score | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups | The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults. | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | z-score | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change in SCr From Baseline to Week 12. | To assess renal glomerular safety by measuring change in SCr from baseline to week 12 by randomized study group; | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change in SCr From Baseline to Week 24. | To assess renal glomerular safety by measuring change in SCr from baseline to week 24 by randomized study group; | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change in SCr From Baseline to Week 48. | To assess renal glomerular safety by measuring change in SCr from baseline to week 48 by randomized study group; | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin) | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | uIU/mL | | Baseline and 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose) | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)) | HOMA-IR is calculated as fasting glucose (mg/dL) X fasting glucose (uIU/mL) / 405. An increase in HOMA-IR means that an individual has become more resistant (less sensitive) to the effects of insulin and thus would be a negative outcome. A reduction in HOMA-IR means that an individual has become more sensitive to the effects of insulin and would be considered a positive outcome.There are no set minimum or maximum scores for HOMA-IR, since it is based on measurements of insulin and glucose, the assays for which may vary. Several studies suggest a cut-off of >2 for any insulin resistance, but "normal" values appear to vary greatly by population (https://www.mdcalc.com/homa-ir-homeostatic-model-assessment-insulin-resistance). | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | units on a scale | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT |
|
| Secondary | Change From Baseline to Week 12 in Serum Calcium (SCa) | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in Serum Calcium (SCa) | | | Posted | | Median | Inter-Quartile Range | mg/dL | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in Serum Calcium (SCa) | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in CTX | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mcg/L | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in CTX | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mcg/L | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in CTX | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mcg/L | | Baseline and week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in OC | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mcg/L | | Baseline and week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in OC | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mcg/L | | Baseline and week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in OC | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mcg/L | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in BAP | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | U/L | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in BAP | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | U/L | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in BAP | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | U/L | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in FGF23 | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | pg/ML | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in FGF23 | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | pg/ML | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in FGF23 | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | pg/ML | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in PTH | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | pg/ML | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in PTH | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | pg/ML | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in PTH | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | pg/ML | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in Actual Free 1,25-OHD | Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd * [VDBP] + Ka *[albumin]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | fmol/L | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change From Baseline to Week 24 in Actual Free 1,25-OHD | Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd * [VDBP] + Ka *[albumin]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | fmol/L | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change From Baseline to Week 48 in Actual Free 1,25-OHD | Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd * [VDBP] + Ka *[albumin]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | fmol/L | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change From Baseline to Week 12 in 1,25-OHD | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | pg/ML | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in 1,25-OHD | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | pg/ML | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in 1,25-OHD | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | pg/ML | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in 25-OHD | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ng/ML | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in 25-OHD | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ng/ML | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in 25-OHD | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ng/ML | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in TRP % | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in TRP % | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in TRP % | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | percent | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in SPO4 | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in SPO4 | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in SPO4 | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 12 in UCa/Ucr | | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ratio | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 24 in UCa/Ucr | | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ratio | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change From Baseline to Week 48 in UCa/Ucr | | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ratio | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Change in Estimated GFR From Baseline to Week 12. | To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 12 by randomized study group. eGFR calculated by the CKD-Epi equation for subjects >=18 years of age, and by bedside Schwartz formula for subjects <18 years of age | Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ml/min/1.73m^2 | | Baseline and wk 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change in Estimated GFR From Baseline to Week 24. | To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 24 by randomized study group; | Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ml/min/1.73m^2 | | Baseline and wk 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change in Estimated GFR From Baseline to Week 48. | To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 48 by randomized study group; | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ml/min/1.73m^2 | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change in UGluc From Baseline to Week 48 | To assess renal tubular function by measuring change in urine glucose (UGluc) by randomized study group; | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change in URBP/UCr Ratio From Baseline to Week 48 | To assess renal tubular function by measuring change in urine retinol binding protein to urine creatinine (URBP/UCr) ratio by randomized study group; | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mcg/g | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change in UB2MG From Baseline to Week 48 | To assess renal tubular function by measuring change in urine beta-2 microglobulin (UB2MG) by randomized study group; | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | mcg/L | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | Change in UProt/ UCr Ratio From Baseline to Week 48 | To assess renal tubular function by measuring change in urinary protein to creatinine ratio by randomized study group; | Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ratio | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
|
| Secondary | 25-OHD Serum Concentration by Randomized Study Group at Week 12 | | Subjects who had wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ng/mL | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | 25-OHD Serum Concentration by Randomized Study Group at Week 24 | | Subjects who had wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ng/mL | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | 25-OHD Serum Concentration by Randomized Study Group at Week 48 | | Subjects who had wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section. | Posted | | Median | Inter-Quartile Range | ng/mL | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group A: Vitamin D3 50,000 IU | Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT | | OG001 | Group B: Vitamin D3 Placebo | Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT |
| |
| Secondary | Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use | Authors were interested in comparing mean 25-OHD at baseline by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section. | Posted | | Mean | Standard Deviation | ng/mL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Efavirenz Use | | | OG001 | No Efavirenz Use | |
| |
| Secondary | Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use | Authors were interested in comparing mean 25-OHD at wk 48 by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section. | Posted | | Mean | Standard Deviation | ng/mL | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Efavirenz Use | | | OG001 | No Efavirenz Use | |
| |
| Secondary | Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use | Authors were interested in comparing the change in mean 25-OHD from baseline to wk 48 by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section. | Posted | | Mean | Standard Deviation | ng/mL | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Efavirenz Use | | | OG001 | No Efavirenz Use | |
| |
| Secondary | Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use | Authors were interested in comparing mean 25-OHD at baseline by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section. | Posted | | Mean | Standard Deviation | ng/mL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Ritonavir Use | | | OG001 | No Ritonavir Use | |
| |
| Secondary | Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use | Authors were interested in comparing mean 25-OHD at wk 48 by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section. | Posted | | Mean | Standard Deviation | ng/mL | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Ritonavir Use | | | OG001 | No Ritonavir Use | |
| |
| Secondary | Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use | Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use | Authors were interested in comparing the change in mean 25-OHD from baseline to wk 48 by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section. | Posted | | Mean | Standard Deviation | ng/mL | | Baseline and wk 48 | | | | ID | Title | Description |
|---|
| OG000 | Ritonavir Use | | | OG001 | No Ritonavir Use | |
| |