DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

Phase 3

Completed

• Conditions: Respiratory Tract Infections; Avitaminosis; Asthma
• Interventions: Drug: Vitamin D - Cholecalciferol 400 IU; Drug: Vitamin D3 - Cholecalciferol 2000 IU

• Registration Number: NCT01419262
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-18
• Study Start: 2011-09
• Primary Completion: 2015-05
• Study Completion: 2015-10
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 703

Inclusion Criteria

1. Healthy children by parental report
2. Have reached their 1st birthday but not past their 6th birthday
3. Present to a TARGet Kids! practice for routine primary healthcare prior to viral season (September through November)
4. Parents provide informed consent to participate.

Exclusion Criteria

1. Children with gestational age < 32 weeks
2. 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
3. Children with a sibling participating in the study to reduce clustering effects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 IU per day vitamin D	Vitamin D - Cholecalciferol 400 IU	-
2000 IU per day vitamin D	Vitamin D3 - Cholecalciferol 2000 IU	-

Primary Outcome Measures

Name	Time	Method
Number of Laboratory confirmed upper respiratory tract infections	Up to 8 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of parent reported upper respiratory tract infections	Up to 8 months	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.
Direct and indirect economic costs associated with upper respiratory tract infections	16 months	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.
Number of Asthma exacerbations	Up to 8 months	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).
Serum vitamin D level	5-8months	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.

Trial Locations

Locations (2)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada