NCT01419262

DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 703 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Tract Infections
• Asthma
• Avitaminosis

Interventions

Type	Name	Description
DRUG	Vitamin D - Cholecalciferol 400 IU	One drop per day (liquid), 400 IU, 4 to 9 months depending on date of enrollment and date of follow-up
DRUG	Vitamin D3 - Cholecalciferol 2000 IU	One drop per day (liquid), 2000 IU, 4 to 9 months depending on date of enrollment and date of follow-up

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-05-01
• Completion: 2015-10-01
• First posted: 2011-08-18
• Last updated: 2019-06-14

Locations

2 sites across 1 country: Canada