DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
DO IT
1 other identifier
interventional
703
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2011
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2011
CompletedFirst Posted
Study publicly available on registry
August 18, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJune 14, 2019
June 1, 2019
3.7 years
August 16, 2011
June 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of parent reported upper respiratory tract infections
Up to 8 months
Number of Asthma exacerbations
Up to 8 months
Serum vitamin D level
5-8months
Direct and indirect economic costs associated with upper respiratory tract infections
16 months
Other Outcomes (3)
Body Mass index z-score
Up to 8 months
Waist circumference z-score
Up to 8 months
Serum Lipids
Up to 8 months
Study Arms (2)
2000 IU per day vitamin D
EXPERIMENTAL400 IU per day vitamin D
ACTIVE COMPARATORInterventions
One drop per day (liquid), 400 IU, 4 to 9 months depending on date of enrollment and date of follow-up
One drop per day (liquid), 2000 IU, 4 to 9 months depending on date of enrollment and date of follow-up
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hospital for Sick Childrenlead
- Mount Sinai Hospital, Canadacollaborator
- Unity Health Torontocollaborator
Study Sites (2)
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (2)
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.
PMID: 33305842DERIVEDAglipay 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.
PMID: 28719693DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathon L Maguire, MD, MSc
St. Michael's Hospital, Toronto, Ontario, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician/ Principal Investigator
Study Record Dates
First Submitted
August 16, 2011
First Posted
August 18, 2011
Study Start
September 1, 2011
Primary Completion
May 1, 2015
Study Completion
October 1, 2015
Last Updated
June 14, 2019
Record last verified: 2019-06