Vitamin D HIV Study on Postmenopausal Women
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01375010 |
Recruitment Status :
Completed
First Posted : June 17, 2011
Results First Posted : March 7, 2019
Last Update Posted : March 7, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Vitamin D3 Other: Placebo Drug: Vitamin Supplements | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Vitamin D Repletion on Postmenopausal Women With HIV |
Actual Study Start Date : | January 2011 |
Actual Primary Completion Date : | February 2016 |
Actual Study Completion Date : | February 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 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.
|
Other: 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.
Other Name: Placebo capsule Drug: 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).
Other Name: Vitamin supplementation |
Experimental: 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.
|
Drug: Vitamin D3
2000 mg QD
Other Name: cholecalciferol-D3 Drug: 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).
Other Name: Vitamin supplementation |
- Change in Bone Mineral Density (BMD) [ Time Frame: Baseline, 12 months ]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: Baseline,12 months ]To evaluate the change in areal BMD (aBMD) at the total hip (TH)
- Change in Volumetric Bone Mineral Density (vBMD) [ Time Frame: Baseline, 12 months ]To evaluate the change in volumetric BMD (VBMD) at the Tibia
- Change in Vitamin D Levels [ Time Frame: 12 months ]To evaluate the change in vitamin D levels with supplementation
- Change in Biochemical Markers [ Time Frame: 12 months ]To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation. (PTH)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375010
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Elizabeth Shane, MD | Columbia University | |
Study Director: | Michael Yin, MD | Columbia University |
Responsible Party: | Elizabeth Shane, Professor of Medicine, Endocrinology, Columbia University |
ClinicalTrials.gov Identifier: | NCT01375010 |
Other Study ID Numbers: |
AAAF2194 2R01AI065200-06A1 ( U.S. NIH Grant/Contract ) |
First Posted: | June 17, 2011 Key Record Dates |
Results First Posted: | March 7, 2019 |
Last Update Posted: | March 7, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
HIV Postmenopausal women Vitamin D |
Vitamin D Cholecalciferol Vitamins Micronutrients |
Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |