Phase 3
N=47
Vitamin D in Preschoolers With Viral-induced Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02197702 ↗Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Dec 2024
Primary outcome: Primary: Change From Baseline in Serum 25OHD — 4.3; 9.6 nmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- vitamin D (Dietary_supplement); placebo (Dietary_supplement)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- St. Justine's Hospital
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum 25OHD |
4.3; 9.6 | — |
| SECONDARY Number of Participants With Total 25OHD ≥75 Nmol/L |
9; 12; 8; 10 | — |
| SECONDARY Emergency Department Visit for an Asthma Flare-up |
1.00; 1.04 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- intake or intention to use more than 400 IU/day of vitamin D supplement
- extreme prematurity ( 1000 IU/ day in last 3 months
- anticipated difficult follow-up (unable to attend clinic visits; plan to leave the province).
Data sourced from ClinicalTrials.gov (NCT02197702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.