- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01419262
DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers (DO IT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- Hospital for sick children
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2000 IU per day vitamin D
|
One drop per day (liquid), 2000 IU, 4 to 9 months depending on date of enrollment and date of follow-up
Other Names:
|
Active Comparator: 400 IU per day vitamin D
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One drop per day (liquid), 400 IU, 4 to 9 months depending on date of enrollment and date of follow-up
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Laboratory confirmed upper respiratory tract infections
Time Frame: 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.
|
Up to 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of parent reported upper respiratory tract infections
Time Frame: 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.
|
Up to 8 months
|
Number of Asthma exacerbations
Time Frame: 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).
|
Up to 8 months
|
Serum vitamin D level
Time Frame: 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.
|
5-8months
|
Direct and indirect economic costs associated with upper respiratory tract infections
Time Frame: 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.
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16 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass index z-score
Time Frame: Up to 8 months
|
Weight and height will be measured at both study baseline and follow-up by trained research assistants.
BMI will be determined by dividing the children's measured weight (kg) by height (m2).
The BMI z-score [zBMI] will be determined using the World Health Organization Growth standards, standardized for age and sex.
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Up to 8 months
|
Waist circumference z-score
Time Frame: Up to 8 months
|
Waist circumference will be measured at both study baseline and follow-up by trained research assistants.
Waist circumference will be measured at the mid-axillary line above the right iliac crest.
Waist circumference z-score will be calculated internally within the entire TARGet Kids! study cohort.
|
Up to 8 months
|
Serum Lipids
Time Frame: Up to 8 months
|
Blood for serum levels will be drawn by trained pediatric phlebotomists from for determination of total cholesterol, low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol and non-HDL cholesterol.
|
Up to 8 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathon L Maguire, MD, MSc, St. Michael's Hospital, Toronto, Ontario, Canada
Publications and helpful links
General Publications
- Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
- Aglipay M, Birken CS, Parkin PC, Loeb MB, Thorpe K, Chen Y, Laupacis A, Mamdani M, Macarthur C, Hoch JS, Mazzulli T, Maguire JL; TARGet Kids! Collaboration. Effect of High-Dose vs Standard-Dose Wintertime Vitamin D Supplementation on Viral Upper Respiratory Tract Infections in Young Healthy Children. JAMA. 2017 Jul 18;318(3):245-254. doi: 10.1001/jama.2017.8708.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Diseases
- Nutrition Disorders
- Deficiency Diseases
- Malnutrition
- Respiratory Tract Infections
- Avitaminosis
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- 1000025147
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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