Abstract
ObjectiveTo determine whether weekly oral vitamin D supplementation influences growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.DesignPhase 3 double-blind randomised placebo-controlled trial.SettingSocioeconomically disadvantaged peri-urban district of Cape Town, South Africa.Participants1682 children of black African ancestry attending government primary schools and aged 6–11 years at baseline.InterventionsOral vitamin D3(10 000 IU/week) versus placebo for 3 years.Main outcome measuresHeight-for-age and body mass index-for-age, measured in all participants; Tanner scores for pubertal development, spirometric lung volumes and body composition, measured in a subset of 450 children who additionally took part in a nested substudy.ResultsMean serum 25-hydroxyvitamin D3concentration at 3-year follow-up was higher among children randomised to receive vitamin D versus placebo (104.3 vs 64.7 nmol/L, respectively; mean difference (MD) 39.7 nmol/L, 95% CI 37.6 to 41.9 nmol/L). No statistically significant differences in height-for-age z-score (adjusted MD (aMD) −0.08, 95% CI −0.19 to 0.03) or body mass index-for-age z-score (aMD −0.04, 95% CI −0.16 to 0.07) were seen between vitamin D versus placebo groups at follow-up. Among substudy participants, allocation to vitamin D versus placebo did not influence pubertal development scores, % predicted forced expiratory volume in 1 s (FEV1), % predicted forced vital capacity (FVC), % predicted FEV1/FVC, fat mass or fat-free mass.ConclusionsWeekly oral administration of 10 000 IU vitamin D3boosted vitamin D status but did not influence growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.Trial registration numbersClinicalTrials.govNCT02880982, South African National Clinical Trials Register DOH-27-0916-5527.
Funder
UK Medical Research Council