Vitamin D to Reduce Colds and Asthma Attacks in Young Children

Phase 2

Completed

• Conditions: Asthma
• Interventions: Dietary Supplement: daily vitamin D supplement; Dietary Supplement: Vitamin D; Other: Placebo

• Registration Number: NCT01999907
• Lead Sponsor: St. Justine's Hospital

Brief Summary

Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-03
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• children aged 1-5 years
• physician-diagnosed asthma as per GINA guidelines
• upper respiratory tract infections as the main asthma exacerbation trigger
• ≥4 respiratory infections in the past 12 months
• ≥1 exacerbation requiring rescue oral steroids in the past 6 months or ≥2 in the previous 12 months.

Exclusion Criteria

• extreme prematurity (<28 weeks gestation)
• infants <12 months of age
• breastfed infants with no vitamin D supplementation
• recent (<1 year) immigrants from countries where rickets and malnutrition prevalent
• other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
• endocrine disorder of calcium/ vitamin D metabolism
• disorder/ disease with associated malabsorption (inflammatory bowel disease)
• kidney/ liver disease
• sickle cell anemia
• medications known to interfere with bone metabolism/ vitamin D levels
• vitamin D supplementation >1000 IU/ day in past 3 months
• unable to attend medical visit in 3-4 months
• plan to leave the province during the next 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	daily vitamin D supplement	bolus placebo given in a 2ml dose by mouth at baseline. This group receives daily vitamin D supplement by mouth for the 6 month study (400IU cholecalciferol per day).
Vitamin D	Vitamin D	Vitamin D (100,000IU) bolus in a 2ml dose by mouth given at baseline. This group receives a daily vitamin D supplement by mouth for 6 months (400IU cholecalciferol per day).
Vitamin D	daily vitamin D supplement	Vitamin D (100,000IU) bolus in a 2ml dose by mouth given at baseline. This group receives a daily vitamin D supplement by mouth for 6 months (400IU cholecalciferol per day).
Placebo	Placebo	bolus placebo given in a 2ml dose by mouth at baseline. This group receives daily vitamin D supplement by mouth for the 6 month study (400IU cholecalciferol per day).

Primary Outcome Measures

Name	Time	Method
serum Vitamin D	3 months	mean change in serum vitamin D from baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
adequate serum vitamin D	3 months	difference in the proportion of children with serum vitamin D ≥75nmol/L at 3 months

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada