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临床试验/JPRN-UMIN000004161
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A randomized, double blind, comparative study of vitamin D3 versus placebo in school children with asthma to prevent asthma attack - ATP XIII

Jikei University School of Medicine0 个研究点目标入组 400 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
400

研究概览

简要总结

BACKGROUND: In our prior randomized trial on preventing influenza, asthma attacks as a secondary outcome occurred less often in the vitamin D group than the placebo group. We aimed to clarify whether low-dose, short-term vitamin D supplementation, in addition to standard treatments, improves control of childhood asthma. METHODS: We conducted a randomized, double-blind, placebo-controlled trial comparing vitamin D3 supplements (800 IU/day) with placebo for 2 months in schoolchildren with asthma. The primary outcomes were frequency and severity of asthma judging from changes of asthma control levels defined by the Global Initiative for Asthma (GINA) by collaborating doctors at 2 and 6 months. RESULTS: Japanese schoolchildren with asthma (n=89) were randomly assigned to receive vitamin D (n=54) or placebo (n=35). At 2 months, GINA asthma control was significantly more improved in the vitamin D group compared with the placebo group (P=0.015). Childhood asthma control test (CACT) scores, a secondary outcome, were also significantly (P=0.004) improved in the vitamin D group compared with the placebo group at 2 months, and differences remained significant (P=0.012) at 6 months. The proportion of patients with a peak expiratory flow rate <80% predicted was significantly less in the vitamin D group (8/54: 15%) than the placebo group (12/35: 34%) at 6 months (P=0.032). CONCLUSIONS: Low-dose, short-term vitamin D supplementation in addition to standard treatment may improve levels of asthma control in schoolchildren. This article is protected by copyright. All rights reserved.

研究设计

研究类型
Interventional

入排标准

年龄范围
6years-old 至 15years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1. Not using vitamin D supplement or active vitamin D 2. Past history incubation and respiratory treatment admission due to RS virus infection urinary stone 3. Chronic disease including fracture mental retardation swallowing disturbance 4. other difficulties judged by the charged doctor

研究者

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