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

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ClinicalTrials.gov Identifier: NCT03365687
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

December 3, 2017
December 7, 2017
December 7, 2017
September 2018
May 2022   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • Laboratory-confirmed respiratory infections [ Time Frame: 7 months ]
    Group difference in mean number of laboratory-confirmed respiratory infections during asthma exacerbations
  • Severity of asthma symptoms during asthma exacerbations [ Time Frame: 7 months ]
    Group difference in the mean severity of asthma symptoms documented on the 'Asthma Flare-up Diary for Young Children'
  • Duration of asthma symptoms during asthma exacerbations [ Time Frame: 7 months ]
    Group difference in the mean duration of asthma symptoms documented on the validated 'Asthma Flare-up Diary for Young Children'
  • Intensity of use of rescue β2-agonists during asthma exacerbations [ Time Frame: 7 months ]
    Group difference in the mean cumulative use of rescue β2-agonists during exacerbations documented on the validated 'Asthma Flare-up Diary for Young Children'
  • Parents' functional status during asthma exacerbations [ Time Frame: 7 months ]
    Group difference in the mean parents' functional status during exacerbation as documented on the validated 'Effect of a child's asthma flare-up on parents questionnaire'
  • Mean number of ED visits for asthma exacerbations [ Time Frame: 7 months ]
    Group difference in number of ED visits for asthma exacerbations
  • De-intensification of preventive asthma therapy [ Time Frame: 7 months ]
    Group difference in proportion of children with de-intensification of preventive asthma therapy
  • Intervention cost-effectiveness [ Time Frame: 7 months ]
    Cost of intervention vs. cost (family expenses and health care) of exacerbations
Same as current
  • Hypercalciuria [ Time Frame: 7 months ]
    Group difference in the proportion of children with ≥1 occurrence of hypercalciuria (urinary calcium: creatinine greater than 1.25 mmol/mmol for children aged 1-2 yrs, or greater than 1 mmol/mmol for those aged 2-5 yrs)
  • Hypercalcemia [ Time Frame: 7 months ]
    Group difference in the proportion of children with ≥1 occurrence of hypercalcemia
  • Elevated serum 25-hydroxyvitamin D [ Time Frame: 7 months ]
    Group difference in the proportion of children with ≥1 occurrence of elevated serum 25OHD (greater than 250 nmol/L)
  • Adverse Health Events [ Time Frame: 7 months ]
    Group difference in the distribution of adverse health events
  • Gene expression [ Time Frame: 3.5 months ]
    Group difference in the change in gene expression between baseline and 3.5 months
  • Serum and nasal metabolome [ Time Frame: 7 months ]
    Group difference in the change in serum and nasal metabolome over 7 months
  • Distribution of laboratory-confirmed respiratory infections [ Time Frame: 7 months ]
    Group difference in the distribution of laboratory-confirmed respiratory infections
  • Lung function [ Time Frame: 7 months ]
    Group difference in the change from baseline in lung function measured by respiratory resistance or lung clearance index at 7 months
  • Bone remodelling [ Time Frame: 3.5 months ]
    Group difference in the change in markers of bone remodelling
  • Severity of respiratory infection [ Time Frame: 7 months ]
    Group difference in the severity of respiratory infection ascertained on the adapted 'Respiratory Symptoms Questionnaire'
Same as current
 
Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers
Vitamin D In the Prevention of Viral-induced Asthma in Preschoolers: a Randomized Controlled Multicenter Trial
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.

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 infection will be screened for enrolment in paediatric asthma, respiratory or allergy clinics and the ED departments and randomized between Sept 1 to November 30, annually (4 recruitment years).

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 7 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, de-intensification of preventive asthma therapy, cost effectiveness, and safety profile. A sample of 432 per arm (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 number of exacerbations requiring OCS per child.

An intention-to-treat (ITT) analysis will be carried out with all randomised children.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a randomised, quadruble-blind, placebo-controlled, parallel-group multicentre trial of vitamin D3 supplementation.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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 login, obtain allocated treatment, prepare the 2 mL bolus in coded syringes and the coded bottles containing the daily dose, and dispense study drugs in masked kits.
Primary Purpose: Prevention
Asthma
  • Dietary Supplement: Vitamin D
    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
    Other Name: Cholecalciferol
  • Dietary Supplement: Placebo
    2 mL of placebo at baseline and at 3.5 months with a daily dose of placebo (1 mL) for 7 months
  • Active Comparator: Vitamin D
    Vitamin D supplement (100,000 IU) orally at baseline and at 3.5 months with daily 400 IU vitamin D for 7 months
    Intervention: Dietary Supplement: Vitamin D
  • Placebo Comparator: Placebo
    Placebo orally at baseline and at 3.5 months with daily placebo during 7 months
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
865
December 2022
May 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 (pharmacy/medical records)
  • ≥4 URTIs in the past 12 months (parental report)
  • URTIs as the main asthma trigger (parental report)

Exclusion Criteria:

  • Intake or intention to use > 400 IU/day of vitamin D3 supplements
  • Extreme prematurity (< 28 week gestation)
  • No vitamin D supplementation when breast-fed
  • Vitamin D restrictive diets, that is, minimal milk intake
  • Recent immigrants from regions at high risk of rickets
  • Recent refugees
  • Undernourished children
  • Other chronic respiratory disease
  • Condition(s) or drug(s) that alter calcium or vitamin D absorption or metabolism
  • Anticipated difficulty with follow-up
Sexes Eligible for Study: All
1 Year to 5 Years   (Child)
No
Contact: Francine M Ducharme, MD 514-345-4931 ext 4398 francine.m.ducharme@umontreal.ca
Contact: Ilona Shemyakina, BSc 514-345-4931 Ext. 7243 ext 4053 ilona.shemyakina@umontreal.ca
Canada
 
 
NCT03365687
MP-21-2018-1657
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Professor Francine Ducharme, St. Justine's Hospital
St. Justine's Hospital
  • Canadian Institutes of Health Research (CIHR)
  • EURO-PHARM International Canada inc.
Principal Investigator: Francine M Ducharme, MD Study Principal Investigator
St. Justine's Hospital
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP