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Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers

NCT03365687 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2025-06-03

No results posted yet for this study

Summary

In this 7-month randomized controlled trial, children aged 1 to less than 6 years, with recurrent 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, and a daily supplement of vitamin D or a placebo. This study will test whether children in vitamin D group 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

  • Asthma
  • Asthma Exacerbations
  • Preschool Child
  • Vitamin D
  • Upper Respiratory Infection
  • Randomized Controlled Study
  • Symptoms
  • Bronchodilator Agents

Interventions

DIETARY_SUPPLEMENT

Vitamin D

2 mL of 50,000 IU/mL at baseline and at 3.5 months with a daily dose of 1 mL (400 IU/mL) for 7 months

DIETARY_SUPPLEMENT

Placebo

2 mL of placebo at baseline and at 3.5 months with a daily dose of placebo (1 mL) for 7 months

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • EURO-PHARM International Canada, Inc.

    collaborator OTHER

  • Professor Francine Ducharme

    lead OTHER

Principal Investigators

  • Francine M Ducharme, MD · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT03365687 on ClinicalTrials.gov