Vitamin D HIV Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: Vitamin D3 Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Vitamin D Repletion on Postmenopausal Women With HIV |
- Change in Bone Mineral Density (BMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months
- Areal Change in Bone Mineral Density (aBMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]To evaluate the change in areal BMD (aBMD) at the total hip (TH), femoral neck (FN), and distal radius (DR);
- Change in Volumetric Bone Mineral Density (vBMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]To evaluate the change in volumetric BMD (VBMD) at the radius, tibia, hips and lumbar spine
- Change in Vitamin D levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]To evaluate the change in vitamin D levels with supplementation
- Change in Biochemical markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation.
- Change in Immune function [ Time Frame: 12 months ] [ Designated as safety issue: No ]To evaluate the effect of vitamin D supplementation on biochemical markers of immune function
- Change in Muscle measures and frailty [ Time Frame: 12 months ] [ Designated as safety issue: No ]To evaluate the effect of vitamin D supplementation on muscle strength.
- Change in Biochemical Markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of inflammation.
- Change in Muscle measures and frailty [ Time Frame: 12 months ] [ Designated as safety issue: No ]To evaluate the effect of vitamin D supplementation on functional muscle performance.
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
1000 IU vitamin D + placebo capsule = 1000 IU/day of vitamin D
|
Drug: Vitamin D3
All subjects will be provided with supplements that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 and will be instructed to take one twice daily with breakfast and dinner. Participants will then be block randomized in a 1:1 ratio with randomly varying block sizes of 2, 4 or 6 to 2000 IU vitamin D3 (Group A) or placebo (Group B). Group A will receive a total of 3000 IU/day, the dose and Group B will receive 1000 IU/day.
Drug: Placebo
Participants will then be block randomized in a 1:1 ratio with randomly varying block sizes of 2, 4 or 6 to 2000 IU vitamin D3 (Group A) or placebo (Group B). Group A will receive a total of 3000 IU/day, the dose and Group B will receive 1000 IU/day.
|
|
Experimental: Group B
1000 IU vitamin D + 2000 IU vitamin D = 3000 IU/day of vitamin D
|
Drug: Vitamin D3
All subjects will be provided with supplements that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 and will be instructed to take one twice daily with breakfast and dinner. Participants will then be block randomized in a 1:1 ratio with randomly varying block sizes of 2, 4 or 6 to 2000 IU vitamin D3 (Group A) or placebo (Group B). Group A will receive a total of 3000 IU/day, the dose and Group B will receive 1000 IU/day.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV+ African American and Latina postmenopausal women, aged 40-70, who meet the standard definition of menopause:
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.
- On stable antiretroviral therapy (ART) for >2 years
- Undetectable HIV RNA (viral load) at least 2 times over the past year (RNA <400)
Exclusion Criteria:
- Metabolic bone disease (Paget's disease, clinical osteomalacia, primary hyperparathyroidism, hypercalcemia)
- Multiple myeloma, solid tumors with metastases;
- Endocrinopathy (hyperthyroidism, untreated hypothyroidism, Cushing's syndrome, prolactin-secreting pituitary adenoma)
- Renal insufficiency (serum creatinine above 1.5 mg/dl)
- Liver disease (AST, ALT, bilirubin, total alkaline phosphatase activity > twice upper normal limit);
- Intestinal disorders (celiac disease, pancreatic insufficiency, Crohn's disease, ulcerative colitis)
- Current use of glucocorticoids, anticonvulsants, anticoagulants, diuretics, methotrexate;
- Current or past use of drug therapies for osteoporosis (raloxifene, bisphosphonates, calcitonin, PTH). Women on estrogen are excluded. Past estrogen use is permitted if discontinued >1 year before enrollment.
- If there is a history of a low trauma fracture, a T score < -3 or a prevalent vertebral fracture on Instant Vertebral Assessment™ (IVA), subjects will be referred for osteoporosis treatment as appropriate.
- Severe vitamin D deficiency (25-OHD level <10 ng/ml) or normal baseline serum vitamin D (25-OHD >32 ng/ml). Subjects with severe vitamin D deficiency may be referred to our sub-study, if all other inclusion/exclusion criteria are met.
- Hypercalcemia or history of calcium-containing kidney stones
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations
- Current imprisonment or voluntary incarceration in a medical facility for psychiatric illness
- Any condition that, in the opinion of the site investigator, would compromised the subject's ability to participate in the study
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01375010
| Contact: Michael Yin, MD | mty4@columbia.edu | ||
| Contact: Mariana Bucovsky | 2123057225 | mb3523@columbia.edu |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Michael Yin, MD mty4@columbia.edu | |
| Principal Investigator: | Elizabeth Shane, MD | Columbia University | |
| Study Director: | Michael Yin, MD | Columbia University |
More Information
No publications provided
| Responsible Party: | Elizabeth Shane, Professor of Medicine, Endocrinology, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01375010 History of Changes |
| Other Study ID Numbers: | AAAF2194, 2R01AI065200-06A1 |
| Study First Received: | June 15, 2011 |
| Last Updated: | August 20, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
HIV Postmenopausal women Vitamin D |
Additional relevant MeSH terms:
|
Ergocalciferols Vitamin D Vitamins Bone Density Conservation Agents |
Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015