DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers (DO IT)
This study has been completed.
Sponsor:
The Hospital for Sick Children
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: November 16, 2015
Last verified: November 2015
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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.
| Enrollment: | 703 |
| Study Start Date: | September 2011 |
| Study Completion Date: | October 2015 |
| 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:
|
Eligibility| Ages Eligible for Study: | 1 Year to 5 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419262
Locations
| Canada, Ontario | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
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
| 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: | November 16, 2015 |
| 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:
|
Respiratory Tract Infections Avitaminosis Infection Respiratory Tract Diseases Deficiency Diseases Malnutrition Nutrition Disorders Vitamins |
Cholecalciferol Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 26, 2016