Vitamin D in Preschoolers With Viral-induced Asthma

NCT02197702 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-12-09

Study results available
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Summary

In this 7-month randomized controlled trial, children aged 1-6 years with asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5 months during their usual clinic visit. This study will test whether children receiving a high dose of vitamin D have less frequent and less severe asthma exacerbations compared with those receiving placebo.The study will also document the safety profile of this strategy.

Conditions

Interventions

DIETARY_SUPPLEMENT

vitamin D

Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter

DIETARY_SUPPLEMENT

placebo

Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER
  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    collaborator OTHER
  • Montreal Children's Hospital of the MUHC

    collaborator OTHER
  • British Columbia Children's Hospital

    collaborator OTHER
  • London Health Sciences Centre

    collaborator OTHER
  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Francine M Ducharme, MD · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02197702 on ClinicalTrials.gov