Dataset Information

Vitamin D₃supplementation 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 (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D).

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 D₃ 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 log₁₀ 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). 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 7000 IU/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±11 ng/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).

Conclusions

In 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 registration

ClinicalTrials.gov NCT02189902.

SUBMITTER: Steenhoff AP

PROVIDER: S-EPMC4338235 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

ACCESS DATA

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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Dataset Information

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

Objectives

Design

Methods

Results

Conclusions

Trial registration

Publications

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

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