DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The Hospital for Sick Children
Sponsor:
Collaborators:
Mount Sinai Hospital, Canada
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Jonathon Maguire, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01419262
First received: August 16, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Respiratory Tract Infections
Asthma
Avitaminosis
Drug: Vitamin D - Cholecalciferol 400 IU
Drug: Vitamin D3 - Cholecalciferol 2000 IU
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Number of Laboratory confirmed upper respiratory tract infections [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of parent reported upper respiratory tract infections [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
    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.

  • Number of Asthma exacerbations [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]
    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).

  • Serum vitamin D level [ Time Frame: 5-8months ] [ Designated as safety issue: Yes ]
    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.

  • Direct and indirect economic costs associated with upper respiratory tract infections [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 750
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2000 IU per day vitamin D 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
Other Name: Ddrops 2000 IU
Active Comparator: 400 IU per day vitamin D 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
Other Names:
  • Baby Ddrops
  • Health Canada NPN #80001869

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419262

Contacts
Contact: Jonathon L Maguire, MD, MSc 416-919-3462 jonathon.maguire@utoronto.ca

Locations
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Jonathon L Maguire, MD, MSc    416-919-3462    jonathon.maguire@utoronto.ca   
Sub-Investigator: Patricia C Parkin, MD         
Sub-Investigator: Catherine S Birken, MD, MSc         
Sub-Investigator: Mark Loeb, MD, MSc         
Sub-Investigator: Muhammad Mamdani, BScPharm         
Sub-Investigator: Kevin Thorpe, MSc         
Sub-Investigator: Tony Mazzuli, MD         
Sub-Investigator: Jeffrey Hoch, PhD         
Principal Investigator: Jonathon L Maguire, MD, MSc         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Jonathon L Maguire, MD, MSc    416-919-3462    jonathon.maguire@utoronto.ca   
Principal Investigator: Jonathon L Maguire, MD, MSc         
Sub-Investigator: Patricia C Parkin, MD         
Sub-Investigator: Catherine S Birken, MD, MSc         
Sub-Investigator: Mark Loeb, MD         
Sub-Investigator: Tony Mazzuli, MD         
Sub-Investigator: Muhammad Mamdani, BScPharm         
Sub-Investigator: Kevin Thorpe, MSc         
Sub-Investigator: Jeffrey Hoch, PhD         
Sponsors and Collaborators
The Hospital for Sick Children
Mount Sinai Hospital, Canada
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Jonathon L Maguire, MD, MSc St. Michael's Hospital, Toronto, Ontario, Canada
  More Information

No publications provided

Responsible Party: Jonathon Maguire, Physician/ Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01419262     History of Changes
Other Study ID Numbers: 1000025147
Study First Received: August 16, 2011
Last Updated: May 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Vitamin D
Randomized Controlled Trial
Child, Preschool
Dietary Supplements
Respiratory Tract Infections
Asthma

Additional relevant MeSH terms:
Avitaminosis
Infection
Respiratory Tract Infections
Deficiency Diseases
Malnutrition
Nutrition Disorders
Respiratory Tract Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014