Vitamin D Supplements for HIV-positive Patients on cART

Completed · Not applicable · Has a placebo group

Conditions studied: HIV-associated Co-morbidities

In brief

The ability of vitamin D to modulate the immune system and strengthen bones may mitigate the adverse medication consequences of HIV/AIDS, but little is known about either the health benefits of vitamin D supplements, or about the optimal dosing regimen for patients on highly active antiretroviral therapy (HAART). This trial is a comparison of two regimens for administering vitamin D and calcium to HIV-positive individuals taking antiviral medications. This study will help physicians make evidence-based decisions about the most effective way to use vitamin D in their patients and enable the design of large multi-center trials in the future.

Key facts

Study ID

NCT01295034

Run by

Andrea Branch

People needed

62

Starts

2011-03-01

Expected to finish

2015-06-01

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• No history or evidence of HIV infection
• HIV viral load positive
• outside the age range

Where it is running

• Icahn School of Medicine Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.