Vitamin D to Reduce Colds and Asthma Attacks in Young Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: daily vitamin D supplement
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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). | Dietary Supplement: daily vitamin D supplement<br>* Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.<br>* Other names: cholecalciferol (Pediavit);Other: Placebo<br>* placebo given in a 2ml dose by mouth at baseline.<br>|
| Active Comparator: Vitamin D<br>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). | Dietary Supplement: Vitamin D<br>* 100,000IU cholecalciferol given in a 2ml dose by mouth at baseline.<br>* Other names: cholecalciferol;Dietary Supplement: daily vitamin D supplement<br>* Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.<br>* Other names: cholecalciferol (Pediavit);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum Vitamin D | mean change in serum vitamin D from baseline to 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate serum vitamin D | difference in the proportion of children with serum vitamin D ≥75nmol/L at 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, virus diseases, pediatric, RCT, steroid