Status:
COMPLETED
Vitamin D in Preschoolers With Viral-induced Asthma
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
The Hospital for Sick Children
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Conditions:
Asthma
Eligibility:
All Genders
1-5 years
Phase:
PHASE2
PHASE3
Brief 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 usu...
Detailed Description
IMPORTANT NOTE: Due to receiving a 2-year partial funding enabling only a single-centre pilot trial, rather than an adequately-powered multicentre study, the primary outcome was modified post hoc for ...
Eligibility Criteria
Inclusion
- age 1-5 years
- physician-diagnosed asthma as per the Global Initiative for Asthma (GINA) guidelines
- URTIs as the main asthma trigger (parental report)
- ≥4 URTIs in the past 12 months (parental report)
- ≥1 asthma exacerbation requiring rescue oral corticosteroids (OCS) in the past 6 months or ≥2 in the past 12 months
Exclusion
- intake or intention to use more than 400 IU/day of vitamin D supplement
- extreme prematurity (\<28 weeks gestation)
- infants \<12 months of age
- no vitamin D supplementation when breast-fed
- recent (\<1 year) immigrants from a region at high risk of rickets
- children with vitamin D restrictive diets e.g. vegans
- other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
- condition(s) that alter calcium or vitamin D metabolism/absorption (hypo/hyperparathyroidism, kidney/liver disease, inflammatory bowel disease)
- medications that interfere with vitamin D metabolism (anti-epileptics, diuretics, antacids, anti-fungal drug)
- vitamin D supplementation \>1000 IU/ day in last 3 months
- anticipated difficult follow-up (unable to attend clinic visits; plan to leave the province).
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02197702
Start Date
September 1 2014
End Date
July 1 2016
Last Update
December 9 2024
Active Locations (1)
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1
CHU Sainte Justine
Montreal, Quebec, Canada, H3T1C5