Vitamin D in HIV-Infected Patients on HAART
This is a research study to look at vitamin D deficiency (low levels) in men and women with HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If your levels are low, and you choose to start using vitamin D supplements, the investigators would like to take some blood before and after you start using vitamin D to see how this affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study. If you and your physician decide that you should continue taking vitamin D supplements after that time, you will be responsible for purchasing your own vitamin D supplements.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vitamin D, Immune Activation, and Metabolic Abnormalities in HIV-Infected Patients on Antiretroviral Therapy|
- Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.
|Study Start Date:||October 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
No Intervention: Vitamin D Sufficient
HIV-infected men and women with HIV-1 viral load <200 copies/mL on stable ART and 25(OH)D level ≥30ng/mL receive no intervention.
Experimental: Vitamin D Insufficient
HIV-infected men and women with HIV-1 viral load <200 copies /mL on stable ART and 25(OH)D level <30ng/mL receive 50,000 IU twice weekly for 5 weeks followed by 2000 IU daily to complete 12 weeks.
Dietary Supplement: Vitamin D
50,000 IU vitamin D3 twice weekly for 5 weeks, followed by 2000 IU daily maintenance supplementation to complete 12 weeks. At the end of the 12-week period, 25(OH)D levels will be checked. If the subject is still deficient, he/she may undergo a second period of supplementation (at the discretion of their provider) to complete a total of 24 weeks. After 24 weeks, we anticipate all subjects will be kept on daily maintenance supplementation by their primary physicians.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250899
|United States, California|
|UCLA CARE Center|
|Los Angeles, California, United States, 90035|
|Study Director:||Judith Currier, M.D.||UCLA-Care Center|
|Principal Investigator:||Jordan Lake, M.D.||UCLA-Care Center|