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Completed

NCT Number: NCT01999907

Vitamin D to Reduce Colds and Asthma Attacks in Young Children

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Virus Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Dietary Supplement

100,000IU cholecalciferol given in a 2ml dose by mouth at baseline.

Other names: cholecalciferol

daily vitamin D supplement

Dietary Supplement

Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.

Other names: cholecalciferol (Pediavit)

Placebo

Other

placebo given in a 2ml dose by mouth at baseline.

Primary outcomes

  1. serum Vitamin D

    Time frame: 3 months

    mean change in serum vitamin D from baseline to 3 months

Secondary outcomes

  1. adequate serum vitamin D

    Time frame: 3 months

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

Other outcomes

  1. exacerbations requiring oral corticosteroids

    Time frame: 6 months

    number of patients with one or more exacerbations requiring oral steroids, as documented by pharmacy dispensation records and medical records

  2. number of viral infections

    Time frame: 6 months

    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

  3. Hypercalciuria

    Time frame: any point during the 6 months

    urinary calcium: creatinine ratio >1.25 (1-2 years) and >1 (2-5 years) mmol/mmol

  4. Cytokine/ chemokine profile

    Time frame: 10 days

    change in serum cytokine/ chemokine profile from baseline to 10 days post-bolus dose

  5. duration of viral infections

    Time frame: in the event of a cold during the 6 months

    number of days with respiratory tract symptoms as reported on the parent completed Canadian Acute Respiratory Illness & Flu Scale

  6. severity of exacerbations

    Time frame: in the event of an exacberbation during the 6 months

    • area under the curve for β-agonist use as documented by parent of the 'Asthma Flare-Up Diary for Young Children';
    • need for hospital admission

  7. duration of exacerbations

    Time frame: in the event of an exacerbation during the 6 months

    Number of days with asthma symptoms as reported on the parent-reported 'Asthma Flare-Up Diary for Young Children'

  8. participant retention

    Time frame: 6 months

    percentage of patients retained until 6 months after randomization

  9. protocol adherence

    Time frame: 6 months

    • 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.

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

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

Acronym: DIVA-pilot

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2013
Registry last updated
Jan 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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