Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers

NCT03365687 | Completed Phase 3 DMC

• 1 other identifier: MP-21-2018-1657
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Asthma; Asthma Exacerbations; Preschool Child; Vitamin D; Upper Respiratory Infection; Randomized Controlled Study; Symptoms; Bronchodilator Agents

Keywords

Children; Vitamin D; Respiratory viral infection; Randomized controlled trial; Asthma exacerbations; intervention; functional status; acute care visits; oral corticosteroids; hypercalciuria; hypercalcemia

Outcome Measures

Primary Outcomes (1)

• 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

  7 months

Secondary Outcomes (11)

• Laboratory-confirmed respiratory infections

  7 months

• Mean number of ED visits and hospital admissions for asthma exacerbations

  7 months

• De-intensification of preventive asthma therapy

  3.5 and 7 months

• Duration of asthma symptoms during asthma exacerbations

  7 months

• Duration of B2-agonist use during asthma exacerbations

  7 months

Other Outcomes (6)

• Hypercalcemia

  7 months

• Hypercalciuria

  7 months

• Elevated serum 25-hydroxyvitamin D

  7 months

Study Arms (2)

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

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo orally at baseline and at 3.5 months with daily placebo during 7 months

Dietary Supplement: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Also known as: Cholecalciferol

Vitamin D

Placebo DIETARY_SUPPLEMENT

2 mL of placebo at baseline and at 3.5 months with a daily dose of placebo (1 mL) for 7 months

Placebo

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Professor Francine Ducharme: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• EURO-PHARM International Canada, Inc.: collaborator

Study Sites (9)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Children's Hospital of London Health Sciences Centre

London, Ontario, N6A 2V5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

CHU Sainte Justine

Montreal, Quebec, H3T1C5, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Location

CHU de Québec-Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

CHU de Sherbrooke

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Related Publications (1)

• 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.

  PMID: 31892662 BACKGROUND

MeSH Terms

Conditions

Asthma; Respiratory Tract Infections; Hypercalciuria; Hypercalcemia

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Infections; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Francine M Ducharme, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The manufacturer, Europharm, will provide the active vitamin D3 and placebo preparations, identical in appearance and taste, in coded latex-free bottles. A web-based randomisation system will allow Site pharmacies to obtain allocated treatment number, prepare the 2 mL bolus in coded syringes and the coded bottles containing the daily dose, and dispense study drugs in masked kits.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatrician

Model Details: This is a randomised, triple-blind, placebo-controlled, parallel-group multicentre trial of vitamin D3 supplementation.

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: December 7, 2017
• Study Start: October 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: approximatively 18 months from datalock (Dec 2026)
• Access Criteria: to be determined

Locations

CA (9)