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This is a research study to look at vitamin D deficiency (low levels) in men and women with HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If your levels are low, and you choose to start using vitamin D supplements, the investigators would like to take some blood before and after you start using vitamin D to see how this affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study. If you and your physician decide that you should continue taking vitamin D supplements after that time, you will be responsible for purchasing your own vitamin D supplements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D Sufficient | No Intervention | HIV-infected men and women with HIV-1 viral load <200 copies/mL on stable ART and 25(OH)D level ≥30ng/mL receive no intervention. | |
| Vitamin D Insufficient | Experimental | HIV-infected men and women with HIV-1 viral load <200 copies /mL on stable ART and 25(OH)D level <30ng/mL receive 50,000 IU twice weekly for 5 weeks followed by 2000 IU daily to complete 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | 50,000 IU vitamin D3 twice weekly for 5 weeks, followed by 2000 IU daily maintenance supplementation to complete 12 weeks. At the end of the 12-week period, 25(OH)D levels will be checked. If the subject is still deficient, he/she may undergo a second period of supplementation (at the discretion of their provider) to complete a total of 24 weeks. After 24 weeks, we anticipate all subjects will be kept on daily maintenance supplementation by their primary physicians. |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation. | Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Currier, M.D. | University of California, Los Angeles | Study Director |
| Jordan Lake, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA CARE Center | Los Angeles | California | 90035 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D Sufficient | HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation. |
| FG001 | Vitamin D Insufficient | HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
HIV-infected men and women with HIV-1 RNA <200 copies/mL on stable ART and daily vitamin D <400IU were enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D Sufficient | HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation. |
| BG001 | Vitamin D Insufficient |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation. | Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation. | After 12 weeks of oral vitamin D supplementation, serum 25(OH)D levels were measured in the Vitamin D Insufficient arm. 81% (n=66) of insufficient persons achieved 25(OH)D ≥30ng/mL (p=0.32 vs. historical controls). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks |
|
12 weeks, 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D Insufficient | 25(OH)D <30 mg/mL at study entry (i.e. group of patients receiving vitamin D supplementation). |
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This trial was prospective, but open label and not randomized. However, randomization to placebo would not have been clinically appropriate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jordan Lake | University of California, Los Angeles | 310-557-2273 | jlake@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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|
|
| 0 |
| 82 |
| 0 |
| 82 |
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| D009750 |
| Nutritional and Metabolic Diseases |