Vitamin D in Preschoolers With Viral-induced Asthma

NCT02197702 | Completed Phase 2 Results DMC

• 1 other identifier: DIVA
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

In this 7-month randomized controlled trial, children aged 1-6 years with 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. This study will test whether children receiving a high dose of vitamin D 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

Keywords

RCT; asthma; pediatric; virus; corticosteroid

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Serum 25OHD

  Group difference in the adjusted change from baseline 25OHD over 7 months

  During the 7-month follow-up period

Secondary Outcomes (2)

• Number of Participants With Total 25OHD ≥75 Nmol/L

  at 3.5 and 7 months

• Emergency Department Visit for an Asthma Flare-up

  During the 7-month follow-up period

Other Outcomes (13)

• Hypercalciuria

  At any point during the 7-month follow-up period

• Elevated Serum 25-hydroxyvitamin D (25OHD)

  At any point during the 7-month follow-up period

• Perturbation of the Calcium Homeostasis

  At any point during the 7-month follow-up period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 ml identical placebo taken by mouth at baseline and 3.5 months.

Dietary Supplement: placebo

Vitamin D

EXPERIMENTAL

Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.

Dietary Supplement: vitamin D

Interventions

vitamin D DIETARY_SUPPLEMENT

Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter

Also known as: cholecalciferol

Vitamin D

placebo DIETARY_SUPPLEMENT

Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter

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 Global Initiative for Asthma (GINA) guidelines
• URTIs as the main asthma trigger (parental report)
• ≥4 URTIs in the past 12 months (parental report)
• ≥1 asthma exacerbation requiring rescue oral corticosteroids (OCS) in the past 6 months or ≥2 in the past 12 months

You may not qualify if:

• intake or intention to use more than 400 IU/day of vitamin D supplement
• extreme prematurity (\<28 weeks gestation)
• infants \<12 months of age
• no vitamin D supplementation when breast-fed
• recent (\<1 year) immigrants from a region at high risk of rickets
• children with vitamin D restrictive diets e.g. vegans
• other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
• condition(s) that alter calcium or vitamin D metabolism/absorption (hypo/hyperparathyroidism, kidney/liver disease, inflammatory bowel disease)
• medications that interfere with vitamin D metabolism (anti-epileptics, diuretics, antacids, anti-fungal drug)
• vitamin D supplementation \>1000 IU/ day in last 3 months
• anticipated difficult follow-up (unable to attend clinic visits; plan to leave the province).

Sponsors & Collaborators

• St. Justine's Hospital: lead
• The Hospital for Sick Children: collaborator
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator
• Montreal Children's Hospital of the MUHC: collaborator
• British Columbia Children's Hospital: collaborator
• London Health Sciences Centre: collaborator

Study Sites (1)

CHU Sainte Justine

Montreal, Quebec, H3T1C5, Canada

Location

Related Publications (2)

• Ducharme FM, Jensen M, Mailhot G, Alos N, White J, Rousseau E, Tse SM, Khamessan A, Vinet B. Impact of two oral doses of 100,000 IU of vitamin D3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial. Trials. 2019 Feb 18;20(1):138. doi: 10.1186/s13063-019-3184-z.

  PMID: 30777118 RESULT

• Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

  PMID: 33305842 DERIVED

Related Links

• article

MeSH Terms

Conditions

Asthma; Virus Diseases

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Francine Ducharme
• Organization: StJustineH

Francine.m.ducharme@umontreal.ca

5143454931

Study Officials

• Francine M Ducharme, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: identical placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 23, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-12

Locations

CA (1)