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维生素 D 缺乏症哮喘患儿补充维生素 D 的疗效:一项随机对照试验(ESDAC 试验)。

Efficacy of vitamin D supplementation in asthmatic children with vitamin D deficiency: A randomized controlled trial (ESDAC trial).

机构信息

Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.

Department of Endocrinology, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Pediatr Allergy Immunol. 2021 Apr;32(3):479-488. doi: 10.1111/pai.13415. Epub 2020 Dec 4.

DOI:10.1111/pai.13415
PMID:33207014
Abstract

BACKGROUND

Vitamin D supplementations for asthma control had shown inconsistent results. We aimed to study efficacy and safety of vitamin D supplementation in asthmatic children who were vitamin D deficient.

METHODS

This double-blind, randomized controlled trial enrolled asthmatic children of 4-12 years of age who had 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL. The participants were randomized to receive either vitamin D orally 1000 IU/d for 9 months or similar-looking placebo. The primary outcomes were the proportion of children having the Childhood Asthma Control Test (CACT) score of ≥20 at the end of the treatment and adverse effects.

RESULTS

The trial included 250 children (125 in each group) with a mean age of 8.1 ± 2.3 years and 180 boys. The baseline parameters were similar between the groups, including CACT score (21.7 ± 4.2 vs 21.9 ± 3.6, vitamin D vs placebo). At the end of the study, the proportion of asthmatic children who had CACT score ≥ 20 was similar between vitamin D and placebo group (93.6% vs 92.0%, P = .625). The number of exacerbations of asthma and side effect profile was also identical between the groups. 25(OH)D levels increased significantly in the vitamin D group (18.06 ± 7.11 vs 12.03 ± 5.98 ng/mL, P < .001). The results did not change when we did subgroup analysis for children with baseline CACT score < 20 and 25(OH)D levels at the end of the study ≥20 ng/mL.

CONCLUSION

Vitamin D supplementation in asthmatic children with vitamin D deficiency did not improve control of asthma.

摘要

背景

维生素 D 补充剂在哮喘控制方面的效果并不一致。我们旨在研究维生素 D 缺乏的哮喘儿童补充维生素 D 的疗效和安全性。

方法

这是一项双盲、随机对照试验,纳入了年龄在 4-12 岁、25-羟维生素 D [25(OH)D]水平<20ng/ml 的哮喘儿童。参与者被随机分为口服维生素 D 1000IU/d,持续 9 个月,或服用外观相似的安慰剂。主要结局是治疗结束时儿童的儿童哮喘控制测试(CACT)评分≥20 的比例和不良反应。

结果

该试验纳入了 250 名儿童(每组 125 名),平均年龄为 8.1±2.3 岁,180 名男孩。两组的基线参数相似,包括 CACT 评分(21.7±4.2 与 21.9±3.6,维生素 D 与安慰剂)。研究结束时,维生素 D 组和安慰剂组 CACT 评分≥20 的哮喘儿童比例相似(93.6%与 92.0%,P=0.625)。哮喘发作次数和不良反应谱也无差异。维生素 D 组 25(OH)D 水平显著升高(18.06±7.11 与 12.03±5.98ng/ml,P<0.001)。当我们对基线 CACT 评分<20 和研究结束时 25(OH)D 水平≥20ng/ml 的儿童进行亚组分析时,结果并未改变。

结论

维生素 D 缺乏的哮喘儿童补充维生素 D 并不能改善哮喘控制。

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