Vitamin D Supplements for HIV-positive Patients on cART
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ClinicalTrials.gov Identifier: NCT01295034 |
Recruitment Status
:
Completed
First Posted
: February 14, 2011
Results First Posted
: April 17, 2017
Last Update Posted
: April 17, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-associated Co-morbidities | Dietary Supplement: conventional vitamin D treatment Drug: tiered/titrated vitamin D dosing | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Vitamin D Supplements for HIV-positive Patients on cART |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: conventional vitamin D treatment
Subjects in Protocol A (the conventional/active placebo arm) will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
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Dietary Supplement: conventional vitamin D treatment
Subjects in Protocol A (the conventional/active placebo arm) will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
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Experimental: tiered/titrated vitamin D dosing
Subjects in Protocol B will receive 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
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Drug: tiered/titrated vitamin D dosing
Subjects in Protocol B will receive 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
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- 25(OH)D Levels [ Time Frame: baseline and 12 months ]The difference in the percentage of subjects with 25(OH)D levels in the range of 30-60 ng/ml at 12 mo between the two arms.
- CD4+T Cell Count [ Time Frame: baseline and 12 months ]The change in the CD4+T cell count between the two arms.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age, 18-70 yr
- HIV-infected
- on a stable HAART regimen for at least 12 mo with an undetectable HIV viral load for 6-mo
- willing to participate
- not receiving vitamin D supplementation in a form other than vitamin D2 or vitamin D3
- not receiving treatment for bone disease
- not receiving medications known to alter bone mineralization
- not suffering from conditions known to affect vitamin D, calcium, and/or phosphate levels (including clinically significant hypocalcemia, primary hyperparathyroidism)
- not experiencing kidney disease based on GFR > 60 min/ml/1.73 m2, 10) 25(OH)D level < 25 ng/ml
- not meeting criteria of the National Osteoporosis Foundation for established bone disease (osteoporosis, osteomalacia) requiring immediate treatment
- not consuming more than 2.0 gm of calcium/day in food and supplements combined outside the trial
- not consuming more than 800IU/day of vitamin D outside the trial
- not suffering from an unstable medical condition likely to preclude participation in a 12 month trial
- able to ingest and absorb food and nutrients
- not pregnant or planning to become pregnant.
Exclusion Criteria:
- No history or evidence of HIV infection
- HIV viral load positive
- outside the age range

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): NCT01295034
United States, New York | |
Icahn School of Medicine Mount Sinai | |
New York, New York, United States, 10029 |
Principal Investigator: | Andrea D Branch, PhD | Icahn School of Medicine Mount Sinai |
Publications:
Responsible Party: | Andrea Branch, Principal Investigator, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT01295034 History of Changes |
Other Study ID Numbers: |
GCO 10-0679 R01DA031095 ( U.S. NIH Grant/Contract ) |
First Posted: | February 14, 2011 Key Record Dates |
Results First Posted: | April 17, 2017 |
Last Update Posted: | April 17, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Andrea Branch, Icahn School of Medicine at Mount Sinai:
HIV combination antiretroviral therapy vitamin D low bone density |
Additional relevant MeSH terms:
Vitamins Vitamin D Ergocalciferols Cholecalciferol |
Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |