Vitamin D in HIV-Infected Patients on HAART
|ClinicalTrials.gov Identifier: NCT01250899|
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : September 5, 2014
Last Update Posted : November 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency HIV||Dietary Supplement: Vitamin D||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vitamin D, Immune Activation, and Metabolic Abnormalities in HIV-Infected Patients on Antiretroviral Therapy|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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.
- Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation. [ Time Frame: 12 weeks ]Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250899
|United States, California|
|UCLA CARE Center|
|Los Angeles, California, United States, 90035|
|Study Director:||Judith Currier, M.D.||University of California, Los Angeles|
|Principal Investigator:||Jordan Lake, M.D.||University of California, Los Angeles|