Ontology highlight
ABSTRACT: Objective
To determine whether weekly oral vitamin D supplementation influences growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.Design
Phase 3 double-blind randomised placebo-controlled trial.Setting
Socioeconomically disadvantaged peri-urban district of Cape Town, South Africa.Participants
1682 children of black African ancestry attending government primary schools and aged 6-11 years at baseline.Interventions
Oral vitamin D3 (10 000 IU/week) versus placebo for 3 years.Main outcome measures
Height-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.Results
Mean serum 25-hydroxyvitamin D3 concentration 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.Conclusions
Weekly oral administration of 10 000 IU vitamin D3 boosted vitamin D status but did not influence growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.Trial registration numbers
ClinicalTrials.gov NCT02880982, South African National Clinical Trials Register DOH-27-0916-5527.
SUBMITTER: Middelkoop K
PROVIDER: S-EPMC11015302 | biostudies-literature | 2024 Apr
REPOSITORIES: biostudies-literature
Middelkoop Keren K Micklesfield Lisa L Stewart Justine J Walker Neil N Jolliffe David A DA Mendham Amy E AE Coussens Anna K AK Nuttall James J Tang Jonathan J Fraser William D WD Momand Waheedullah W Cooper Cyrus C Harvey Nicholas C NC Wilkinson Robert J RJ Bekker Linda-Gail LG Martineau Adrian R AR
BMJ paediatrics open 20240410 1
<h4>Objective</h4>To determine whether weekly oral vitamin D supplementation influences growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.<h4>Design</h4>Phase 3 double-blind randomised placebo-controlled trial.<h4>Setting</h4>Socioeconomically disadvantaged peri-urban district of Cape Town, South Africa.<h4>Participants</h4>1682 children of black African ancestry attending government primary schools and aged 6-11 years at baseline.<h4>Interven ...[more]