Vitamin D Supplements for HIV-positive Patients on cART

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrea Branch
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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