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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01AI065200-06A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this study is to determine the effects of vitamin D on measures of bone health and immune function in HIV infected postmenopausal women. The investigators prior research with this population revealed that low vitamin D levels are very common. Prior research with this population also revealed that Vitamin D is necessary for the body to absorb calcium and is important for the health of the bones. When vitamin D levels are low, there are increased risks of bone loss, muscle weakness, falls and fractures. Low levels of vitamin D have also been associated with impaired immune function. This study will help us learn whether two different doses of vitamin D will improve bone health and immune function.
The purpose of this study is to determine the effects of vitamin D repletion on rates of bone loss and indices of immune function in HIV+ postmenopausal women. Lower baseline serum Vitamin D levels, as assessed by measuring serum 25-hydroxyvitamin D (25-OHD) were associated with a trend toward more bone loss. In addition, the investigators found that despite providing supplements that contained approximately 600 IU vitamin D, serum 25-OHD did not increase during the first year. Provision of adequate calcium and vitamin D is the cornerstone of effective prevention and therapy of osteoporosis. HIV-infected patients may be at increased risk of having vitamin D deficiency because they take several medications that may interfere with vitamin D action. Therefore, the investigators will recruit 100 HIV infected postmenopausal women for this study who are on a stable antiretroviral therapy (ART) regimen and randomize them to receive 1000 or 3000 IU of vitamin D daily. The subjects will be followed closely for one year to monitor compliance and changes in bone health and immune function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Placebo Comparator | Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU. |
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| Group B | Experimental | 2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | 2000 mg QD |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mineral Density (BMD) | Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Areal Change in Bone Mineral Density (aBMD) | To evaluate the change in areal BMD (aBMD) at the total hip (TH) | Baseline,12 months |
| Change in Volumetric Bone Mineral Density (vBMD) | To evaluate the change in volumetric BMD (VBMD) at the Tibia |
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Inclusion Criteria:
If 50 years old or older then amenorrhea for > 1year. If age 40 to 49 then amenorrhea for over a year and and Follicle-Stimulating Hormone (FSH) level of equal to or greater than 20 mIU/ml; as some amenorrheic chronically ill women may have hypothalamic dysfunction and low FSH values, if FSH is 10 to 19, and the serum estradiol level is consistent with menopause less than or equal to 30pg/ml, she will be determined to be postmenopausal.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Shane, MD | Columbia University | Principal Investigator |
| Michael Yin, MD | Columbia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU. Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3. Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D). |
| FG001 | Group B | 2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU. Vitamin D3: 2000 mg QD Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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HIV-infected postmenopausal African American or Hispanic women between ages 40-70 were recruited from 4 sites in New York City. All participants had serum 25-OHD ≥10 ng/mL and < 32 ng/mL and were on stable ART for at least 2 years with 2 or more HIV RNA levels <400 copies/ml within the last year prior to enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU. Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3. Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Bone Mineral Density (BMD) | Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months | A complete case approach was utilized for outcome in participants with BMD data at 12 months (n=69). | Posted | Mean | Standard Deviation | percentage change | Baseline, 12 months |
|
1 year
Adverse event reporting was collected at every visit as part of the protocol.
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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 | Group A | Placebo vitamin D3 capsule daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 1000 IU. Placebo: An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3. Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal bleeding/ hemorrhage | Gastrointestinal disorders | Systematic Assessment | Evidence of internal and external hemorrhoids |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Shane, MD | Columbia University | 212-305-6289 | es54@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Other | An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3. |
|
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| Vitamin Supplements | Drug | Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D). |
|
|
| Baseline, 12 months |
| Change in Vitamin D Levels | To evaluate the change in vitamin D levels with supplementation | 12 months |
| Change in Biochemical Markers | To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation. (PTH) | 12 months |
| BG001 | Group B | 2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU. Vitamin D3: 2000 mg QD Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Group B | 2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU. Vitamin D3: 2000 mg QD Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D). |
|
|
| Secondary | Areal Change in Bone Mineral Density (aBMD) | To evaluate the change in areal BMD (aBMD) at the total hip (TH) | A complete case approach was utilized for outcome in participants with BMD data at 12 months (n=69). | Posted | Mean | Standard Deviation | percentage of change | Baseline,12 months |
|
|
|
| Secondary | Change in Volumetric Bone Mineral Density (vBMD) | To evaluate the change in volumetric BMD (VBMD) at the Tibia | A complete case approach was utilized for secondary outcomes in participants with vBMD data at 12 months (n=69). | Posted | Mean | Standard Deviation | percentage of change | Baseline, 12 months |
|
|
|
| Secondary | Change in Vitamin D Levels | To evaluate the change in vitamin D levels with supplementation | A complete case approach was utilized for secondary outcomes in participants with data at 12 months (n=69). | Posted | Mean | Standard Deviation | percentage of change | 12 months |
|
|
|
| Secondary | Change in Biochemical Markers | To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation. (PTH) | A complete case approach was utilized for secondary outcomes in participants with data at 12 months (n=69). | Posted | Mean | Standard Deviation | percentage of change | 12 months |
|
|
|
| 0 |
| 43 |
| 1 |
| 43 |
| 6 |
| 43 |
| EG001 | Group B | 2000 IU vitamin D3 daily plus vitamin supplements that contains 1000 IU vitamin D3 and 1000 mg calcium carbonate daily. Total daily vitamin D3 dose = 3000 IU. Vitamin D3: 2000 mg QD Vitamin Supplements: Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D). | 0 | 42 | 1 | 42 | 5 | 42 |
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| Cardiac Ischemia | Cardiac disorders | Systematic Assessment | Infarction |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Kidney Stones | Renal and urinary disorders | Systematic Assessment | Asymptomatic kidney stones at baseline visit scans |
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| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |