Status:
COMPLETED
Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers
Lead Sponsor:
Professor Francine Ducharme
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
EURO-PHARM International Canada, Inc.
Conditions:
Asthma
Asthma Exacerbations
Eligibility:
All Genders
1-5 years
Phase:
PHASE3
Brief 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...
Detailed Description
This is a multicenter triple-blind randomized parallel-group, placebo-controlled trial of vitamin D3 supplementation. Children aged 1-5 (\<6) years with physician-diagnosed asthma predominantly trigge...
Eligibility Criteria
Inclusion
- Age 1-5 years
- Physician-diagnosed asthma (as per the 2015 Canadian Position Paper on the diagnosis of preschool asthma)
- ≥1 asthma exacerbation requiring rescue oral corticosteroids (OCS) in the past 6 months or ≥2 in the past 12 months; or from the pandemic (2020) onwards, ≥1 asthma exacerbation requiring rescue oral corticosteroids (OCS) in the past 12 months (as documented by pharmacy/medical records)
- ≥4 upper respiratory tract infections (URTIs) in the past 12 months (as per parental report); or from the pandemic (2020) onwards, ≥ 2 URTIs in past 12 months
- URTIs as the main asthma trigger (as per parental report)
Exclusion
- Intake \> 400 IU/day of vitamin D3 supplements or fish oil in the past 3 months
- Intention to use \> 400 IU/day of vitamin D3 supplements or fish oil in the fall and winter
- Extreme prematurity (\< 28 week gestation)
- No vitamin D supplementation (if breast-fed in the last 6 months)
- Vitamin D restrictive diets, that is, minimal intake of vitamin D fortified milk (\<250 mL/day for 1-3 years or \<375 mL/day for 4-6 years AND no other (or \<200 IU/day) vitamin D supplement
- Recent immigrants from regions at high risk of rickets (in the past 12 months)
- Recent refugees (in the past 12 months)
- Undernourished children
- Other chronic respiratory disease (e.g. Cystic fibrosis, Bronchopulmonary dysplasia) or chronic kidney, gastrointestinal, endocrinological or cardiac diseases, or sickle cell anemia
- History of bone disorder disease (e.g. rickets, osteomalacia)
- Intake of oral anti-epileptic, diuretic or anti-fungal medications
- Anticipated difficulty with follow-up or with adherence to the intervention or the procedures
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT03365687
Start Date
October 1 2018
End Date
December 31 2024
Last Update
June 3 2025
Active Locations (9)
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1
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
2
Children's Hospital of London Health Sciences Centre
London, Ontario, Canada, N6A 2V5
3
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
4
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8