Vitamin D Supplementation in HIV
|HIV-infection/Aids||Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Safe and Effective Vitamin D Supplementation in HIV|
- Vitamin D Supplementation Safety [ Time Frame: 12 months ]elevated serum calcium (above age-specific range) associated with elevated serum 25D (>160 ng/mL)
|Study Start Date:||July 2011|
|Study Completion Date:||February 2017|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 7000IU/day
29 subjects will be randomized to receive 7000IU/day of vitamin D3.
Dietary Supplement: Vitamin D3
7000IU per day of vitamin D3 for 12 months.
Placebo Comparator: Placebo
29 subjects will be randomized to receive placebo.
Dietary Supplement: Placebo
Once a day for 12 months.
Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS. The impact of vit D supplementation will be evaluated for safety and efficacy using clinically important outcomes, and this will overcome the critical barrier for use of vit D supplementation in research and clinical care. Inexpensive and easy to administer, vit D supplementation may prove to be an effective and feasible treatment for symptoms and prevention of side effects for people of all ages living with HIV/AIDS in the US and around the world.
The study is a 12-month randomized, double blind, placebo-controlled study of vitamin D3 (vit D) supplementation using 7000IU/day based on evidence from the Vit D Dose Finding Study-IRB 09-007332 in 58 subjects with both Perinatally Acquired (PA) and Behaviorally Acquired (BA) HIV/AIDS to assess the long-term safety in terms of serum calcium and 25OHD concentrations, and efficacy in terms of the effect of vit D supplementation on 25OHD, cathelicidin, growth (pre- and peripubertal participants), body composition, bone, muscle, immune and inflammatory status and HIV/AIDS disease severity and progression.
H1: Vit D supplementation is safe and does not result in an increased incidence of elevated serum calcium (above age-specific range) associated with elevated serum 25OHD (>160 ng/mL) in treated subjects compared with the subjects receiving placebo.
H2: Vit D supplementation is significantly associated with both increased 25D and cathelicidin in treated subjects compared with subjects receiving placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475890
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Virginia A Stallings, MD||Children's Hospital of Philadelphia|