AsthmaPhase 3DIVANCT03365687
Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers
A Phase 3 study testing Vitamin D in people with Asthma and Asthma Exacerbations, run by Professor Francine Ducharme at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Asthma, Asthma Exacerbations, Preschool Child
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 9 sitesCanada
- Study dates
- 1 Oct 2018to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 12Show fewer
- 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
- History of bone disorder disease (e.g. rickets, osteomalacia)
- Intake of oral anti-epileptic, diuretic or anti-fungal medications
- Anticipated difficulty with follow-up or with adherence to the intervention or the procedures
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Children's Hospital of London Health Sciences Centre
London, Ontario, N6A 2V5
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
CHU Sainte Justine
Montreal, Quebec, H3T1C5
Maisonneuve-Rosemont Hospital
Montreal, Quebec
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
CHU de Québec-Université Laval
Québec, Quebec, G1V 4G2
CHU de Sherbrooke
Sherbrooke, Quebec, J1G 2E8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers: a Randomized Controlled Multicenter Trial (DIVA)
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.
Read the detailed description
This is a multicenter triple-blind randomized parallel-group, placebo-controlled trial of vitamin D3 supplementation. Children aged 1-5 (<6) years with physician-diagnosed asthma predominantly triggered by upper respiratory tract infections will be screened for enrolment in paediatric asthma, respiratory or allergy clinics and the ED departments and randomized between Sept 1 to January 31, annually (4 recruitment years) and year around from 2022 onwards.
Using a computer-generated random list, stratified by site, children will be allocated (1:1) using permuted block randomisation method to enhance concealment.
Children will be followed for 7 months, with 3 visits every 3.5 months with repeated urine (for calcium:creatinine ratio) and blood samples. In addition, ten (10) days after each bolus, urine will be sampled for urinary calcium:creatinine ratio. In case of elevated urine calcium:creatinine ratio, a blood sample may be needed primarily for markers of calcium metabolism and exploratory outcomes. Only patients enrolled at CHU Sainte-Justine and Montreal Children's Hospital will receive a systematic home visit 10 days after first bolus for both urine and blood samples. There will be 6 follow-up phone calls, at week 1 and then monthly, to inquire about exacerbations and URTIs, remind parents to complete questionnaires and to collect a nasal swab at each exacerbation and screen for adverse events.
The main outcome is the number of courses of rescue oral corticosteroids (OCS) per child during the study period. Several secondary outcomes will be documented using biological samples and validated questionnaires to ascertain laboratory-confirmed respiratory infections, intensity and severity of exacerbations, mean number of ED visits, parents' functional status during exacerbations, de-intensification of preventive asthma therapy, cost effectiveness, and safety profile.
A sample of 432 children (400+7,5% attrition) per arm will provide 80% power with a two-tailed alpha of 5% to detect a 25% relative reduction in the mean number of exacerbations requiring OCS per child.
An intention-to-treat (ITT) analysis will be carried out with all randomised children.
- Conditions
- Asthma, Asthma Exacerbations, Preschool Child, Vitamin D, Upper Respiratory Infection, Randomized Controlled Study
- Being tested
- Vitamin D, Placebo
- Keywords
- Children, Vitamin D, Respiratory viral infection, Randomized controlled trial, Asthma exacerbations, intervention, functional status, acute care visits, oral corticosteroids, hypercalciuria, hypercalcemia
- Medical subject headings
- Asthma, Respiratory Tract Infections, Hypercalciuria, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Cholecalciferol
2 mL of 50,000 IU/mL at baseline and at 3.5 months with a daily dose of 1 mL (400 IU/mL) for 7 months
PlaceboDietary supplement
2 mL of placebo at baseline and at 3.5 months with a daily dose of placebo (1 mL) for 7 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Vitamin D supplement (100,000 IU) orally at baseline and at 3.5 months with daily 400 IU vitamin D for 7 months Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Placebo orally at baseline and at 3.5 months with daily placebo during 7 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of asthma exacerbations per child treated with rescue oral corticosteroids
Group difference in the mean number of exacerbations treated with rescue oral corticosteroids/child
Measured: 7 months
Secondary outcomes (11)
Laboratory-confirmed respiratory infections
Group difference in (i) mean number of laboratory-confirmed respiratory infections per child and (ii) distribution of viruses during colds and/or asthma exacerbations
Measured: 7 months
Mean number of ED visits and hospital admissions for asthma exacerbations
Group difference in mean number of ED visits and hospital admissions for asthma exacerbations per child
Measured: 7 months
De-intensification of preventive asthma therapy
Group difference in proportion of children with de-intensification of preventive asthma therapy
Measured: 3.5 and 7 months
Duration of asthma symptoms during asthma exacerbations
Group difference in the mean duration of symptoms during asthma exacerbations per child (i) documented in writing on the validated 'Asthma Flare-up Diary for Young Children' and (ii) reported verbally by parents,
Measured: 7 months
Duration of B2-agonist use during asthma exacerbations
Group difference in the mean duration of B2-agonist use during asthma exacerbations per child (i) documented in writing on the validated 'Asthma Flare-up Diary for Young Children' and (ii) reported verbally by parents,
Measured: 7 months
Severity of asthma symptoms during asthma exacerbations
Group difference in the severity of symptoms during asthma exacerbations per child documented on the 'Asthma Flare-up Diary for Young Children'
Measured: 7 months
Intensity of use of rescue β2-agonists during asthma exacerbations
Group difference in the mean cumulative use of rescue β2-agonists per child during exacerbations documented on the validated 'Asthma Flare-up Diary for Young Children'
Measured: 7 months
Parents' functional status during asthma exacerbations
Group difference in the mean parents' functional status during asthma exacerbations per child as documented on the validated 'Effect of a child's asthma flare-up on parents questionnaire'
Measured: 7 months
Number of parental workdays lost
Group difference in the cumulative number of days of work or regular planned activities missed by parents to care for their child during asthma exacerbations
Measured: 7 months
Parental productivity
Group difference in the extent to which parents were able to perform their work or regular planned activities during their child's acute asthma exacerbation (%)
Measured: 7 months
Intervention cost-effectiveness
Cost of intervention vs. cost (family expenses and health care) of exacerbations
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Oct 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised, triple-blind, placebo-controlled, parallel-group multicentre trial of vitamin D3 supplementation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Francine Ducharme
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), EURO-PHARM International Canada, Inc.
- Responsible party
- Sponsor-investigator, Professor Francine Ducharme, St. Justine's Hospital
- Investigators
- Francine M Ducharme, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365687
- Sponsor's protocol ID
- MP-21-2018-1657
- Acronym
- DIVA
- Status last verified
- May 2025
- First submitted
- 3 Dec 2017
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available
Publications
Jensen ME, Ducharme FM, Alos N, Mailhot G, Masse B, White JH, Sadatsafavi M, Khamessan A, Tse SM, Alizadehfar R, Bock DE, Daigneault P, Lemire C, Yang C, Radhakrishnan D. 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 Dec 30;9(12):e033075. doi: 10.1136/bmjopen-2019-033075.
PubMed 31892662Ducharme FM, Tse SM, Daigneault P, Lee Yang C, Radhakrishnan D, Alizadehfar R, Turcot MA, Lemire C, Chen BA, Perrem L, Mailhot G, Alos N, Smyrnova A, Kang Dufour MS, Fernandez MC, Jensen ME, White JH, Sadatsafavi M, Khamessan A, Masse B. 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 Oct 4;100:104216. doi: 10.1016/j.eclinm.2026.104216. eCollection 2026 Oct.
PubMed 42871976El Abd A, Trottier H, Tse SM, Masse B, Mailhot G, Alos N, Chen BA, Jensen ME, Radhakrishnan D, Yang CL, Ducharme FM. Impact of vitamin D status and supplementation on exploratory inflammatory biomarkers in preschoolers with asthma. Ann Allergy Asthma Immunol. 2026 Jul;137(1):53-63.e4. doi: 10.1016/j.anai.2026.03.022. Epub 2026 Apr 9.
PubMed 41966354
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers: a Randomized Controlled Multicenter Trial (DIVA)
- ClinicalTrials.gov ID
- NCT03365687
- Acronym / sponsor ID
- DIVA / MP-21-2018-1657
- Conditions
- Asthma, Asthma Exacerbations, Preschool Child, Vitamin D, Upper Respiratory Infection, Randomized Controlled Study
- Keywords
- Children, Vitamin D, Respiratory viral infection, Randomized controlled trial, Asthma exacerbations, intervention, functional status, acute care visits
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Professor Francine DucharmeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), EURO-PHARM International Canada, Inc.
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter triple-blind randomized parallel-group, placebo-controlled trial of vitamin D3 supplementation. Children aged 1-5 (<6) years with physician-diagnosed asthma predominantly triggered by upper respiratory tract infections will be screened for enrolment in paediatric asthma, respiratory or allergy clinics and the ED departments and randomized between Sept 1 to January 31, annually (4 recruitment years) and year around from 2022 onwards.
Using a computer-generated random list, stratified by site, children will be allocated (1:1) using permuted block randomisation method to enhance concealment.
Children will be followed for 7 months, with 3 visits every 3.5 months with repeated urine (for calcium:creatinine ratio) and blood samples. In addition, ten (10) days after each bolus, urine will be sampled for urinary calcium:creatinine ratio. In case of elevated urine calcium:creatinine ratio, a blood sample may be needed primarily for markers of calcium metabolism and exploratory outcomes. Only patients enrolled at CHU Sainte-Justine and Montreal Children's Hospital will receive a systematic home visit 10 days after first bolus for both urine and blood samples. There will be 6 follow-up phone calls, at week 1 and then monthly, to inquire about exacerbations and URTIs, remind parents to complete questionnaires and to collect a nasal swab at each exacerbation and screen for adverse events.
The main outcome is the number of courses of rescue oral corticosteroids (OCS) per child during the study period. Several secondary outcomes will be documented using biological samples and validated questionnaires to ascertain laboratory-confirmed respiratory infections, intensity and severity of exacerbations, mean number of ED visits, parents' functional status during exacerbations, de-intensification of preventive asthma therapy, cost effectiveness, and safety profile.
A sample of 432 children (400+7,5% attrition) per arm will provide 80% power with a two-tailed alpha of 5% to detect a 25% relative reduction in the mean number of exacerbations requiring OCS per child.
An intention-to-treat (ITT) analysis will be carried out with all randomised children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomised, triple-blind, placebo-controlled, parallel-group multicentre trial of vitamin D3 supplementation.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: Vitamin DVitamin D supplement (100,000 IU) orally at baseline and at 3.5 months with daily 400 IU vitamin D for 7 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo orally at baseline and at 3.5 months with daily placebo during 7 months |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Cholecalciferol2 mL of 50,000 IU/mL at baseline and at 3.5 months with a daily dose of 1 mL (400 IU/mL) for 7 months | Dietary supplement | Vitamin D |
| Placebo2 mL of placebo at baseline and at 3.5 months with a daily dose of placebo (1 mL) for 7 months | Dietary supplement | Placebo |
Primary outcome
Number of asthma exacerbations per child treated with rescue oral corticosteroids
Time frame: 7 months
Group difference in the mean number of exacerbations treated with rescue oral corticosteroids/child
11 secondary outcomes
Laboratory-confirmed respiratory infections
Time frame: 7 months
Mean number of ED visits and hospital admissions for asthma exacerbations
Time frame: 7 months
De-intensification of preventive asthma therapy
Time frame: 3.5 and 7 months
Duration of asthma symptoms during asthma exacerbations
Time frame: 7 months
Duration of B2-agonist use during asthma exacerbations
Time frame: 7 months
Severity of asthma symptoms during asthma exacerbations
Time frame: 7 months
Intensity of use of rescue β2-agonists during asthma exacerbations
Time frame: 7 months
Parents' functional status during asthma exacerbations
Time frame: 7 months
Number of parental workdays lost
Time frame: 7 months
Parental productivity
Time frame: 7 months
Intervention cost-effectiveness
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 31892662Jensen ME, Ducharme FM, Alos N, Mailhot G, Masse B, White JH, Sadatsafavi M, Khamessan A, Tse SM, Alizadehfar R, Bock DE, Daigneault P, Lemire C, Yang C, Radhakrishnan D. 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 Dec 30;9(12):e033075. doi: 10.1136/bmjopen-2019-033075.
- Derived from this study: PubMed 42871976Ducharme FM, Tse SM, Daigneault P, Lee Yang C, Radhakrishnan D, Alizadehfar R, Turcot MA, Lemire C, Chen BA, Perrem L, Mailhot G, Alos N, Smyrnova A, Kang Dufour MS, Fernandez MC, Jensen ME, White JH, Sadatsafavi M, Khamessan A, Masse B. 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 Oct 4;100:104216. doi: 10.1016/j.eclinm.2026.104216. eCollection 2026 Oct.
- Derived from this study: PubMed 41966354El Abd A, Trottier H, Tse SM, Masse B, Mailhot G, Alos N, Chen BA, Jensen ME, Radhakrishnan D, Yang CL, Ducharme FM. Impact of vitamin D status and supplementation on exploratory inflammatory biomarkers in preschoolers with asthma. Ann Allergy Asthma Immunol. 2026 Jul;137(1):53-63.e4. doi: 10.1016/j.anai.2026.03.022. Epub 2026 Apr 9.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francine M Ducharme, MD principal investigator
Study Principal Investigator
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Asthma and Asthma Exacerbations, run by Professor Francine Ducharme at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of asthma exacerbations per child treated with rescue oral corticosteroids (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03365687, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.