NCT03365687CompletedPhase 3
Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers
Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers: a Randomized Controlled Multicenter Trial (DIVA)
Source: ClinicalTrials.gov · Last updated 3 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 323 (actual)
- First submitted
- 3 Dec 2017
- Start date
- 1 Oct 2018
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Professor Francine Ducharme
- Diseases
- Asthma
- NCT number
- NCT03365687
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 323
- From 1 Oct 2018 to the primary completion date, 31 Dec 2024
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intake of oral anti-epileptic, diuretic or anti-fungal medications
Other illness
- 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)
Other
- 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
- Anticipated difficulty with follow-up or with adherence to the intervention or the procedures
Who the study is looking for
- 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)
Age in the registry: 1 year to 5 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CHU Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Maisonneuve-Rosemont Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Montreal Children's Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Children'S Hospital Of Eastern Ontario Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| CHU de Quebec-Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| CHU de Sherbrooke Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| British Columbia Children's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
Related publications
- High-dose vitamin D3 supplementation in the prevention of viral-induced asthma in high-morbidity preschoolers (DIVA): a randomised controlled trial in Canada.EClinicalMedicine · 2026 · PMID 42871976
- Impact of vitamin D status and supplementation on exploratory inflammatory biomarkers in preschoolers with asthma.Ann Allergy Asthma Immunol · 2026 · PMID 41966354
- Vitamin D in the prevention of exacerbations of asthma in preschoolers (DIVA): protocol for a multicentre randomised placebo-controlled triple-blind trial.BMJ Open · 2019 · PMID 31892662
This page is information, not medical advice. Discuss any trial with your doctor.