Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers (NCT03365687) | Clinical Trial Compass
CompletedPhase 3
Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers
Canada323 participantsStarted 2018-10-01
Plain-language 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.
Who can participate
Age range1 Year – 5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
* Histor…
What they're measuring
1
Number of asthma exacerbations per child treated with rescue oral corticosteroids