Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease
Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease
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DOI：
10.1056/nejmoa1915176
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发表时间：
2020-07-23
影响因子：
158.5
通讯作者：
Martineau, Adrian R.
中科院分区：
文献类型：
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作者：
Ganmaa, Davaasambuu;Uyanga, Buyanjargal;Martineau, Adrian R.
维生素D缺乏的儿童结核分枝杆菌阴性结果随机分配接受每周剂量的维生素D(3)或安慰剂。在3岁时，两组之间在测试结果为阳性的儿童比例上没有差异。肺结核。维生素D代谢物支持结核分枝杆菌的先天免疫反应。缺乏补充维生素D预防结核病感染的3期随机对照试验的数据。方法随机抽取结果为阴性的患儿。根据QuantiFERON-TB金管试验（QFT），接受每周14000国际单位维生素D(3)或安慰剂的口服剂量，为期3年。主要结果是在3年随访中获得积极的QFT结果，以儿童的比例表示。次要结局包括试验结束时血清25-羟基维生素D （25[OH]D）水平、结核病、急性呼吸道感染和不良事件的发生率。结果共有8851名儿童接受了随机分组：4418名儿童被分配到维生素D组，4433名儿童被分配到安慰剂组；95.6%的儿童基线血清25(OH)D水平低于20 ng / ml。在试验结束时获得有效QFT结果的儿童中，维生素D组的阳性百分比为3.6%（4074名儿童中的147名），安慰剂组的阳性百分比为3.3%（4043名儿童中的134名）（调整后的风险比为1.10；95%可信区间[CI]， 0.87至1.38；P=0.42）。试验结束时，维生素D组的平均25(OH)D水平为31.0 ng /毫升，安慰剂组为10.7 ng /毫升（组间平均差为20.3 ng /毫升；95% CI为19.9至20.6）。维生素D组有21名儿童被诊断患有结核病，安慰剂组有25名儿童被诊断患有结核病（调整后的风险比为0.87；95% CI为0.49至1.55）。维生素D组共有29名儿童和安慰剂组34名儿童因急性呼吸道感染住院治疗（校正风险比为0.86；95% CI为0.52至1.40）。两组不良事件发生率无显著差异。结论：在蒙古维生素D缺乏的学童中，补充维生素D并没有导致结核病感染、结核病或急性呼吸道感染的风险低于安慰剂。（由美国国立卫生研究院资助；ClinicalTrials.gov号码，.）
Vitamin D-deficient children who had negative results forMycobacterium tuberculosiswere randomly assigned to receive a weekly dose of vitamin D(3)or placebo. At 3 years, there was no difference between the groups in the proportion of children who had a positive test result forM. tuberculosis.Background Vitamin D metabolites support innate immune responses toMycobacterium tuberculosis. Data from phase 3, randomized, controlled trials of vitamin D supplementation to prevent tuberculosis infection are lacking. Methods We randomly assigned children who had negative results forM. tuberculosisinfection according to the QuantiFERON-TB Gold In-Tube assay (QFT) to receive a weekly oral dose of either 14,000 IU of vitamin D(3)or placebo for 3 years. The primary outcome was a positive QFT result at the 3-year follow-up, expressed as a proportion of children. Secondary outcomes included the serum 25-hydroxyvitamin D (25[OH]D) level at the end of the trial and the incidence of tuberculosis disease, acute respiratory infection, and adverse events. Results A total of 8851 children underwent randomization: 4418 were assigned to the vitamin D group, and 4433 to the placebo group; 95.6% of children had a baseline serum 25(OH)D level of less than 20 ng per milliliter. Among children with a valid QFT result at the end of the trial, the percentage with a positive result was 3.6% (147 of 4074 children) in the vitamin D group and 3.3% (134 of 4043) in the placebo group (adjusted risk ratio, 1.10; 95% confidence interval [CI], 0.87 to 1.38; P=0.42). The mean 25(OH)D level at the end of the trial was 31.0 ng per milliliter in the vitamin D group and 10.7 ng per milliliter in the placebo group (mean between-group difference, 20.3 ng per milliliter; 95% CI, 19.9 to 20.6). Tuberculosis disease was diagnosed in 21 children in the vitamin D group and in 25 children in the placebo group (adjusted risk ratio, 0.87; 95% CI, 0.49 to 1.55). A total of 29 children in the vitamin D group and 34 in the placebo group were hospitalized for treatment of acute respiratory infection (adjusted risk ratio, 0.86; 95% CI, 0.52 to 1.40). The incidence of adverse events did not differ significantly between the two groups. Conclusions Vitamin D supplementation did not result in a lower risk of tuberculosis infection, tuberculosis disease, or acute respiratory infection than placebo among vitamin D-deficient schoolchildren in Mongolia. (Funded by the National Institutes of Health; ClinicalTrials.gov number,.)