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DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

NCT01419262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 703

Last updated 2019-06-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    collaborator OTHER

  • Unity Health Toronto

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Jonathon L Maguire, MD, MSc · St. Michael's Hospital, Toronto, Ontario, Canada

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-05-31
Completion
2015-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01419262 on ClinicalTrials.gov