Vitamin D3 Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial: e0117123

Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D3) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change ( Delta 25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0-50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D3 and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) greater than or equal to 32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean plus or minus SD) 19.5 plus or minus 11.8 years, CD4% 31.8 plus or minus 10.4, with baseline VL log sub(1)0 range of 1.4) in 22%. From baseline to 12 weeks, 25D increased from 36 plus or minus 9ng/ml to 56 plus or minus 18ng/ml (p