View Clinical Trial (Medical Research Study)
The Effect of Vitamin D Repletion on Postmenopausal Women With HIV
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10032 |
| Conditions: |
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HIV |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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Inclusion Criteria:
- HIV+ African American and Latina postmenopausal women, aged 40-70, who meet the
standard definition of menopause: amenorrhea for > 1year and Follicle-Stimulating
Hormone (FSH) level of >30 mIU/ml; as some amenorrheic chronically ill women may have
hypothalamic dysfunction and low FSH values, we will also accept amenorrhea for >
1year if their age is > 55 years old.
- On stable antiretroviral therapy (ART) for >2 years
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 < -2.5 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 >30 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 kidney stones
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| NCT ID: |
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NCT01375010 |
| Primary Contact: |
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Principal Investigator
Elizabeth Shane, MD
Columbia University
Michael Yin, MD
Email: mty4@columbia.edu
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| Backup Contact: |
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Email: pc2403@columbia.edu
Polly Young, MPH
Phone: 2123057225
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| Location Contact: |
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New York, New York 10032
United States
Michael Yin, MD
Email: mty4@columbia.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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