DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

Study Overview
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Brief Summary
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Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. However, no study has determined whether vitamin D supplementation can reduce the risk of these conditions in young children where they are most common and most severe. The goals of this study are to determine whether wintertime high dose vitamin D supplementation of preschoolers can prevent colds and asthma attacks. The investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with Vitamin D during the winter. The investigators believe that preschoolers receiving 'high dose' vitamin D supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and will be less likely to use the medical system and keep their parents away from work.

Official Title
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DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

Conditions
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Respiratory Tract Infections, Asthma, Avitaminosis

Intervention / Treatment
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* Drug: Vitamin D - Cholecalciferol 400 IU
* Drug: Vitamin D3 - Cholecalciferol 2000 IU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children by parental report Have reached their 1st birthday but not past their 6th birthday Present to a TARGet Kids! practice for routine primary healthcare prior to viral season (September through November) Parents provide informed consent to participate. Exclusion Criteria: Children with gestational age < 32 weeks Children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin D metabolism and increase the risk of respiratory infection Children with a sibling participating in the study to reduce clustering effects.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2000 IU per day vitamin D<br> | Drug: Vitamin D3 - Cholecalciferol 2000 IU<br>* One drop per day (liquid), 2000 IU, 4 to 9 months depending on date of enrollment and date of follow-up<br>* Other names: Ddrops 2000 IU;|
| Active Comparator: 400 IU per day vitamin D<br> | Drug: Vitamin D - Cholecalciferol 400 IU<br>* One drop per day (liquid), 400 IU, 4 to 9 months depending on date of enrollment and date of follow-up<br>* Other names: Health Canada NPN #80001869;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Laboratory confirmed upper respiratory tract infections | Parents of enrolled children will be asked to obtain a nasal swab from their child and complete a symptom checklist with each URTI. Reverse transcriptase polymerase chain reaction will be performed on each sample. Samples will be tested for 18 common respiratory viruses using the ID-TagTM RVP assay using the Luminex xMAPTM system. | Up to 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of parent reported upper respiratory tract infections | Parental reported URTI symptoms will be defined as two or more of fever, cough, runny nose, sore throat, headache, vomiting, feels unwell, muscle aches, ear ache or infection, poor appetite, not sleeping well, cranky/fussy, low energy or crying more than usual from a validated parent completed symptom checklist. | Up to 8 months | 
| Number of Asthma exacerbations | Asthma exacerbation will be defined as a wheezing episode in children with asthma as obtained from parent completed symptom checklist based on the International Study of Asthma and Allergies in Childhood (ISAAC). | Up to 8 months | 
| Serum vitamin D level | Blood for serum levels will be drawn by trained pediatric phlebotomists from for determination of 25-hydroxyvitamin D. Total 25-hydroxyvitamin D will be measured from serum samples using a competitive two-step chemiluminescence assay. | 5-8months | 
| Direct and indirect economic costs associated with upper respiratory tract infections | Cost-consequence and cost-effectiveness analyses will be conducted using data from this clinical trial. A societal perspective will be employed as both direct health service utilization costs as well as indirect costs to families from URTI will be calculated for the 400 IU per day versus 2000 IU per day groups. | 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Randomized Controlled Trial, Child, Preschool, Dietary Supplements, Respiratory Tract Infections, Asthma