A randomized, double blind, comparative study of vitamin D3 versus placebo in school children with asthma to prevent asthma attack

Not Applicable

Completed

• Conditions: asthma

• Registration Number: JPRN-UMIN000004161
• Lead Sponsor: Jikei University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-01
• Study Completion: 2013-10-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
frequencies and severity of asthma attack diagnosed by collaborating doctors

Secondary Outcome Measures

Name	Time	Method
Improvement of IgE RIST, RAST, SCORAD, changes of ACT score reduce of drug usage