Clinical trial NCT01419262: DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
Official title: DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Tract Infections
Asthma
Avitaminosis
Keywords: Vitamin D
Randomized Controlled Trial
Child, Preschool
Dietary Supplements
Respiratory Tract Infections
Asthma
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Canada
name: Unity Health Toronto
First posted: 2011-08-18
Enrollment: 703
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Laboratory confirmed upper respiratory tract infections
timeFrame: Up to 8 months
Secondary outcomes:
measure: Number of parent reported upper respiratory tract infections
timeFrame: Up to 8 months
measure: Number of Asthma exacerbations
timeFrame: Up to 8 months
measure: Serum vitamin D level
timeFrame: 5-8months
measure: Direct and indirect economic costs associated with upper respiratory tract infections
timeFrame: 16 months
Other outcomes:
measure: Body Mass index z-score
timeFrame: Up to 8 months
measure: Waist circumference z-score
timeFrame: Up to 8 months
measure: Serum Lipids
timeFrame: Up to 8 months
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: St. Michael's Hospital, Toronto, Ontario, Canada
name: Jonathon L Maguire, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.