Dataset Information

Vitamin D?supplementation in Batswana children and adults with HIV: a pilot double blind randomized controlled trial.

ABSTRACT:

Objectives

Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D?) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (?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 7000 IU per day of D? and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ?32 ng/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±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log?? range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9 ng/ml to 56±18 ng/ml (p<0.0001) and 68% and 90% had 25D ?32 ng/ml, respectively (p = 0.02). ?25D 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 7000 IU/d group (p<0.04). Younger (5-13y) and older (30-50y) subjects had greater ?25D than those 14-29y (26±17 and 28±12 vs. 11±11 ng/ml, respectively, p?0.001). ?25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p?0.03).

Conclusions

In a pilot study in Botswana, 12-week high dose D? supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers.

Trial registration

ClinicalTrials.gov NCT02189902.

SUBMITTER: Steenhoff AP

PROVIDER: S-EPMC4338235 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

Vitamin D₃supplementation in Batswana children and adults with HIV: a pilot double blind randomized controlled trial.

Steenhoff Andrew P AP Schall Joan I JI Samuel Julia J Seme Boitshepo B Marape Marape M Ratshaa Bakgaki B Goercke Irene I Tolle Michael M Nnyepi Maria S MS Mazhani Loeto L Zemel Babette S BS Rutstein Richard M RM Stallings Virginia A VA

PloS one 20150223 2

<h4>Objectives</h4>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 (Δ25D).<h4>Design</h4>Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0-50.9 years.<h4>Methods</h4>Sixty subjects randomized within five age groups to either 4000 or 7000 IU per day of D₃ and evaluated for vitamin D, parathyroid hormo ...[more]

PMID: 25706751

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