NCT01999907

Vitamin D to Reduce Colds and Asthma Attacks in Young Children

Vitamin D vs. Placebo in the Prevention of Viral-induced Exacerbations in Preschoolers With Asthma: a Pilot RCT

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: St. Justine's Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	100,000IU cholecalciferol given in a 2ml dose by mouth at baseline.
DIETARY_SUPPLEMENT	daily vitamin D supplement	Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.
OTHER	Placebo	placebo given in a 2ml dose by mouth at baseline.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2013-12-03
• Last updated: 2015-01-12

Locations

1 site across 1 country: Canada