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维生素 D 补充作为儿童哮喘标准治疗的辅助手段:一项随机对照试验(ViDASTA 试验)。

Vitamin-D supplementation as an adjunct to standard treatment of asthma in children: A randomized controlled trial (ViDASTA Trial).

机构信息

Department of Pediatrics, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.

Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Pediatr Pulmonol. 2021 Jun;56(6):1427-1433. doi: 10.1002/ppul.25287. Epub 2021 Feb 1.

Abstract

OBJECTIVE

To determine the role of vitamin D supplementation as an adjunct to standard treatment in childhood asthma.

STUDY DESIGN

In this placebo-controlled, blinded, randomized controlled trial, we enrolled 60 children aged 6 to 11 years with moderate persistent asthma and randomly assigned them into intervention (2000 IU per day of vitamin D) and placebo groups (n = 30 each). The primary outcome was asthma control as assessed by the childhood asthma control test (C-ACT) scores at 12 weeks post-randomization. The secondary outcomes were improvement in the forced expiration in 1 s (FEV ), fractional exhaled nitric oxide (FeNO), asthma exacerbations, use of systemic steroids, number of emergency visits, post-intervention vitamin D levels, and adverse outcomes. We analyzed by intention to treat.

RESULTS

There was no significant difference between the C-ACT score in the two groups (median [first-third quartile] scores were 25 [24-26] in both groups, p = 0.7). Also, there was no significant difference between the two groups in terms of the FEV , FeNO, number of exacerbations, emergency visits, hospital admissions, and adverse outcomes. However, the post-intervention vitamin D levels (ng/ml) were significantly higher in the intervention group (35.5 vs. 18.8; p < 0.001). As compared to the baseline, both the groups showed better asthma control at 12 weeks post-intervention, irrespective of the type of intervention.

CONCLUSION

Vitamin-D supplementation as an adjunct to standard treatment does not improve asthma control in children.

摘要

目的

确定维生素 D 补充剂作为标准治疗的辅助手段在儿童哮喘中的作用。

研究设计

在这项安慰剂对照、双盲、随机对照试验中,我们招募了 60 名年龄在 6 至 11 岁的中度持续性哮喘儿童,并将他们随机分为干预组(每天 2000IU 维生素 D)和安慰剂组(每组 30 名)。主要结局是通过儿童哮喘控制测试(C-ACT)评分在随机分组后 12 周评估的哮喘控制情况。次要结局是 1 秒用力呼气量(FEV )、呼气中一氧化氮分数(FeNO)的改善、哮喘加重、全身类固醇的使用、急诊就诊次数、干预后维生素 D 水平以及不良结局。我们采用意向治疗进行分析。

结果

两组的 C-ACT 评分无显著差异(中位数[第一至第三四分位数]评分分别为 25[24-26],p=0.7)。此外,两组在 FEV 、FeNO、发作次数、急诊就诊次数、住院次数和不良结局方面也无显著差异。然而,干预组的干预后维生素 D 水平(ng/ml)显著升高(35.5 与 18.8;p<0.001)。与基线相比,两组在干预后 12 周都显示出更好的哮喘控制,无论干预类型如何。

结论

维生素 D 补充剂作为标准治疗的辅助手段并不能改善儿童的哮喘控制。

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