Desmond Tutu HIV Centre, Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Department of Medicine, University of Cape Town, Cape Town, South Africa.
BMJ Paediatr Open. 2024 Apr 10;8(1):e002495. doi: 10.1136/bmjpo-2024-002495.
To determine whether weekly oral vitamin D supplementation influences growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.
Phase 3 double-blind randomised placebo-controlled trial.
Socioeconomically disadvantaged peri-urban district of Cape Town, South Africa.
1682 children of black African ancestry attending government primary schools and aged 6-11 years at baseline.
Oral vitamin D (10 000 IU/week) versus placebo for 3 years.
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.
Mean serum 25-hydroxyvitamin D 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.
Weekly oral administration of 10 000 IU vitamin D boosted vitamin D status but did not influence growth, body composition, pubertal development or spirometric outcomes in South African schoolchildren.
ClinicalTrials.gov NCT02880982, South African National Clinical Trials Register DOH-27-0916-5527.
确定每周口服维生素 D 补充剂是否会影响南非学童的生长、身体成分、青春期发育或肺功能。
3 期双盲随机安慰剂对照试验。
南非开普敦社会经济劣势的城市周边地区。
1682 名黑人非洲血统的儿童，在基线时年龄为 6-11 岁，就读于政府小学。
口服维生素 D（10000IU/周）与安慰剂治疗 3 年。
所有参与者身高与年龄的比值和体重与年龄的比值；一部分 450 名儿童（他们还参加了一项嵌套子研究）的青春期发育、肺功能肺活量和身体成分的 Tanner 评分。
在 3 年随访时，接受维生素 D 治疗的儿童血清 25-羟维生素 D 浓度中位数高于接受安慰剂的儿童（分别为 104.3 和 64.7nmol/L，平均差异（MD）39.7nmol/L，95%置信区间（CI）37.6 至 41.9nmol/L）。在身高与年龄的比值 z 评分（调整 MD（aMD）-0.08，95%CI-0.19 至 0.03）或体重与年龄的比值 z 评分（aMD-0.04，95%CI-0.16 至 0.07）方面，维生素 D 组与安慰剂组在随访时无显著差异。在子研究参与者中，与安慰剂相比，维生素 D 组的青春期发育评分、预计 1 秒用力呼气量（FEV1）的百分比、预计用力肺活量（FVC）的百分比、FEV1/FVC 的预计百分比、脂肪量或无脂肪量均无影响。
每周口服 10000IU 维生素 D 可提高维生素 D 水平，但对南非学童的生长、身体成分、青春期发育或肺功能无影响。
ClinicalTrials.gov NCT02880982，南非国家临床试验注册 DOH-27-0916-5527。
