Vitamin D to Reduce Colds and Asthma Attacks in Young Children

Asthma Clinical Trial

— DIVA-pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999907
• Other study ID #: VD0001
• Secondary ID: 12140
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2013
• Last updated: January 8, 2015
• Start date: November 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Dietary Supplement:
• Vitamin D
100,000IU cholecalciferol given in a 2ml dose by mouth at baseline.
• 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.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	exacerbations requiring oral corticosteroids	number of patients with one or more exacerbations requiring oral steroids, as documented by pharmacy dispensation records and medical records	6 months	No
Other	number of viral infections	number of patients/person-month of observation documented two days; parent-reported on the Canadian Acute Respiratory Illness and Flu Scale and; Positive viral presence, determined by polymerase chain reaction on nasal sample	6 months	No
Other	Hypercalciuria	urinary calcium: creatinine ratio >1.25 (1-2 years) and >1 (2-5 years) mmol/mmol	any point during the 6 months	Yes
Other	Cytokine/ chemokine profile	change in serum cytokine/ chemokine profile from baseline to 10 days post-bolus dose	10 days	No
Other	duration of viral infections	number of days with respiratory tract symptoms as reported on the parent completed Canadian Acute Respiratory Illness & Flu Scale	in the event of a cold during the 6 months	No
Other	severity of exacerbations	area under the curve for ß-agonist use as documented by parent of the 'Asthma Flare-Up Diary for Young Children'; need for hospital admission	in the event of an exacberbation during the 6 months	No
Other	duration of exacerbations	Number of days with asthma symptoms as reported on the parent-reported 'Asthma Flare-Up Diary for Young Children'	in the event of an exacerbation during the 6 months	No
Other	participant retention	percentage of patients retained until 6 months after randomization	6 months	No
Other	protocol adherence	participant attendance to all 4 home and clinic visits; percentage of patients with all 4 blood and urine tests collected; percentage of analyzable viral nasal swabs returned.	6 months	No
Primary	serum Vitamin D	mean change in serum vitamin D from baseline to 3 months	3 months	No
Secondary	adequate serum vitamin D	difference in the proportion of children with serum vitamin D =75nmol/L at 3 months	3 months	No