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Vitamin D for Preventing Viral-Induced Asthma in Children (DIVA Trial)

Phase 3
Waitlist Available
Led By Francine M Ducharme, MD
Research Sponsored by Professor Francine Ducharme
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 1-5 years
≥4 upper respiratory tract infections (URTIs) in the past 12 months (as per parental report)
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 months
Awards & highlights
Pivotal Trial

Summary

This trial will test whether giving children with asthma high doses of vitamin D will help prevent asthma exacerbations.

Who is the study for?
This trial is for preschool children aged 1-5 with physician-diagnosed asthma, who've had at least four cold-triggered asthma attacks in the past year and have used oral corticosteroids for an attack within six months. It's not for kids with bone diseases, high vitamin D intake, extreme prematurity, certain diets or medication use, undernourishment, or other chronic conditions.
What is being tested?
The study tests if a high dose of Vitamin D given every 3.5 months plus daily supplements can reduce the frequency and severity of asthma attacks caused by colds in young children compared to a placebo over seven months.
What are the potential side effects?
While Vitamin D is generally safe, potential side effects may include increased calcium levels leading to stomach pain and kidney issues. However, this trial will closely monitor safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 and 5 years old.
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I have had 4 or more colds or similar infections in the last year.
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My doctor diagnosed me with asthma following the 2015 Canadian guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a chronic condition like cystic fibrosis or heart disease.
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I have a history of bone disorders like rickets or osteomalacia.
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I have been taking vitamin D3 or fish oil supplements regularly.
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I am taking medication for epilepsy, water retention, or fungal infections.
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My child is undernourished.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of asthma exacerbations per child treated with rescue oral corticosteroids
Secondary study objectives
De-intensification of preventive asthma therapy
Duration of asthma symptoms during asthma exacerbations
Intensity of use of rescue β2-agonists during asthma exacerbations
+5 more
Other study objectives
Adverse Health Events
Elevated serum 25-hydroxyvitamin D
Gene expression
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Vitamin DActive Control1 Intervention
Vitamin D supplement (100,000 IU) orally at baseline and at 3.5 months with daily 400 IU vitamin D for 7 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo orally at baseline and at 3.5 months with daily placebo during 7 months

Find a Location

Who is running the clinical trial?

Professor Francine DucharmeLead Sponsor
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,750 Total Patients Enrolled
14 Trials studying Asthma
7,824 Patients Enrolled for Asthma
EURO-PHARM International Canada, Inc.OTHER
1 Previous Clinical Trials
766 Total Patients Enrolled

Media Library

Asthma Research Study Groups: Placebo, Vitamin D
~0 spots leftby Dec 2024
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