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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01419262
Other study ID # 1000025147
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2011
Est. completion date October 2015

Study information

Verified date June 2019
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 703
Est. completion date October 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 5 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Canada Hospital for Sick Children Toronto Ontario
Canada St. Michael's Hospital Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
The Hospital for Sick Children Mount Sinai Hospital, Canada, St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Body Mass index z-score Weight and height will be measured at both study baseline and follow-up by trained research assistants. BMI will be determined by dividing the children's measured weight (kg) by height (m2). The BMI z-score [zBMI] will be determined using the World Health Organization Growth standards, standardized for age and sex. Up to 8 months
Other Waist circumference z-score Waist circumference will be measured at both study baseline and follow-up by trained research assistants. Waist circumference will be measured at the mid-axillary line above the right iliac crest. Waist circumference z-score will be calculated internally within the entire TARGet Kids! study cohort. Up to 8 months
Other Serum Lipids Blood for serum levels will be drawn by trained pediatric phlebotomists from for determination of total cholesterol, low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol and non-HDL cholesterol. Up to 8 months
Primary Number of Laboratory confirmed upper respiratory tract infections 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. Up to 8 months
Secondary Number of parent reported upper respiratory tract infections 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. Up to 8 months
Secondary Number of Asthma exacerbations 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). Up to 8 months
Secondary Serum vitamin D level 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. 5-8months
Secondary Direct and indirect economic costs associated with upper respiratory tract infections 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. 16 months
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