Phase 2
N=85
Vitamin D HIV Study on Postmenopausal Women
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01375010 ↗Enrolled (actual)
85
Serious AEs
2.4%
Results posted
Mar 2019
Primary outcome: Primary: Change in Bone Mineral Density (BMD) — 0.4; -0.8 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D3 (Drug); Placebo (Other); Vitamin Supplements (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Mineral Density (BMD) |
0.4; -0.8 | — |
| SECONDARY Areal Change in Bone Mineral Density (aBMD) |
-0.5; -0.8 | — |
| SECONDARY Change in Volumetric Bone Mineral Density (vBMD) |
-0.3; -0.9 | — |
| SECONDARY Change in Vitamin D Levels |
33.7; 64.1 | — |
| SECONDARY Change in Biochemical Markers |
-7.2; -16.8 | — |
Summary
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.
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT01375010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.