Abstract
ObjectivesSince 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 (Δ25D).DesignProspective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years.MethodsSixty 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) ≥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.ResultsSubjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000IU/d group (p<0.04). Younger (5–13y) and older (30–50y) subjects had greater Δ25D than those 14–29y (26±17 and 28±12 vs. 11±11ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03).ConclusionsIn a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers.Trial RegistrationClinicalTrials.gov NCT02189902
Highlights
Suboptimal vitamin D status is common in people with HIV [1,2,3]
Efficacy was defined as serum 25 hydroxy vitamin D (25D) 32ng/mL, and safety as no simultaneous elevation of serum calcium and 25-hydroxy vitamin D (25D)
Serum 25-hydroxy vitamin D (25D) concentration was positively correlated with CD4+ counts in Norway [6], Germany [7,8] and in the USA [1]
Summary
Suboptimal vitamin D status is common in people with HIV [1,2,3]. Observational studies suggest that vitamin D status may impact HIV disease severity [1,6,7,8,9]. In Africa, vitamin D insufficiency and rickets are prevalent despite adequate sunlight exposure [10]. Data on vitamin D status in HIV-infected people from sub-Saharan Africa are limited. In HIV-infected adults from Botswana a quarter of subjects were vitamin D insufficient [13]. Despite these data suggesting that vitamin D insufficiency is prevalent in parts of Africa, the cholecalciferol (D3) dose needed to improve vitamin D status in this setting is unknown
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