Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids)
Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids)
复制标题
补充维生素 D 以预防南非学童的结核感染：多中心 3 期双盲随机安慰剂对照试验 (ViDiKids)
DOI：
10.1016/j.ijid.2023.05.010
复制
发表时间：
2023
影响因子：
8.4
通讯作者：
Middelkoop K
中科院分区：
文献类型：
--
作者：
Middelkoop K
目的确定每周口服补充10，000 IU维生素D3 3 3年是否可降低对M的致敏风险。tuberculosisin南非学龄儿童年龄6-11岁，阴性QuantiFERON-结核病（TB）金加（QFT-Plus）分析结果在basel.MethodsWe进行了3期随机安慰剂对照试验，在1682名儿童参加23所小学在开普敦。主要结局是试验结束时QFT-Plus的阳性结果，使用混合效应logistic回归模型进行分析，将上学的学校作为随机效应。安慰剂，分别。随机分配至维生素D组和安慰剂组的受试者研究结束时25（OH）D浓度平均值分别为104.3 nmol/l和64.7 nmol/l（差异的95%置信区间为37.6 - 41.9 nmol/l）。共76/667（11.4%）参与者分配到维生素D组，89/687（13.0%）分配至安慰剂组的受试者在3年随访时QFT-Plus检测呈阳性（校正比值比0.86，95%可信区间0.62- 1.19，P = 0.35）。000 IU维生素D3治疗3年可提高开普敦QFT-Plus阴性学童的血清25（OH）D浓度，但不能降低其QFT-Plus转换的风险。
ObjectivesTo determine whether weekly oral supplementation with 10,000 IU vitamin D3for 3 years reduces the risk of sensitization toM. tuberculosisin South African schoolchildren aged 6-11 years with negative QuantiFERON-tuberculosis (TB) Gold Plus (QFT-Plus) assay results at baseline.MethodsWe conducted a phase 3 randomized placebo-controlled trial in 1682 children attending 23 primary schools in Cape Town. The primary outcome was a positive end-trial QFT-Plus result, analyzed using a mixed effects logistic regression model with the school of attendance included as a random effect.Results829 vs. 853 QFT-Plus-negative children were randomized to receive vitamin D3vs. placebo, respectively. Mean end-study 25(OH)D concentrations in participants randomized to vitamin D vs. placebo were 104.3 vs 64.7 nmol/l, respectively (95% confidence interval for difference, 37.6 to 41.9 nmol/l). A total of 76/667 (11.4%) participants allocated to vitamin D vs. 89/687 (13.0%) participants allocated to placebo tested QFT-Plus positive at 3-year follow-up (adjusted odds ratio 0.86, 95% confidence interval 0.62-1.19,P= 0.35).ConclusionWeekly oral supplementation with 10,000 IU vitamin D3for 3 years elevated serum 25(OH)D concentrations among QFT-Plus-negative Cape Town schoolchildren but did not reduce their risk of QFT-Plus conversion.