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

Phase 3
Recruiting
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
≥1 asthma exacerbation requiring rescue oral corticosteroids (OCS) in the past 6 months or ≥2 in the past 12 months (as documented by pharmacy/medical records)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 months
Awards & highlights

DIVA 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.Check my eligibility
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.See study design
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.

DIVA Trial 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've needed steroids for asthma attacks at least once in 6 months or twice in 12 months.
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My asthma mainly flares up with upper respiratory infections.
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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.

DIVA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of asthma exacerbations per child treated with rescue oral corticosteroids
Secondary outcome measures
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 outcome measures
Adverse Health Events
Elevated serum 25-hydroxyvitamin D
Gene expression
+2 more

DIVA 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?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,243 Total Patients Enrolled
14 Trials studying Asthma
8,024 Patients Enrolled for Asthma
Professor Francine DucharmeLead Sponsor
EURO-PHARM International Canada, Inc.OTHER
1 Previous Clinical Trials
766 Total Patients Enrolled

Media Library

Asthma Research Study Groups: Vitamin D, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Vitamin D been cleared by the FDA?

"There is some clinical data to support the efficacy of Vitamin d, and it has undergone multiple rounds of testing to confirm its safety."

Answered by AI

In how many places can people participate in this trial?

"This trial is taking place in multiple locations, including CHU Sainte Justine in Montreal, British Columbia Children's Hospital in Vancouver, Maisonneuve-Rosemont Hospital in Québec, and 7 other hospitals."

Answered by AI

Are adults of eligible for this clinical trial?

"Children aged 1 to 5 who meet the other inclusion criteria specified by the trial may participate. There are 115 clinical trials currently underway for patients under 18 and 198 for those 65 and older."

Answered by AI

How many test subjects are being used for this research?

"That is correct. The listing on clinicaltrials.gov says that the trial is currently recruiting. The trial was first posted on 10/1/2018 and was most recently edited on 4/25/2022. The clinical trial is looking for 865 patients across 7 sites."

Answered by AI

Are patients able to join this clinical trial at this time?

"That is correct, the study is still recruiting patients. The trial was initially posted on October 1st, 2018 and was updated as recently as April 25th, 2022. The research team is looking to enroll 865 individuals from 7 different sites."

Answered by AI

Who would this clinical trial be appropriate for?

"The team conducting this study needs 865 young patients that have a history of asthma. The age range they are looking for is 1 year to 5 years old. It is essential that applicants meet the following requirements: having had at least 1 asthma attack in the past 6 months that required oral corticosteroids OR having had at least 2 asthma attacks in the past year (this must be documented by pharmacy or medical records), having had at least 4 upper respiratory tract infections in the past year (this must be reported by a parent or guardian)."

Answered by AI
~160 spots leftby Jul 2025