DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

Asthma Clinical Trial

— DO IT  

Official title:

DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419262
• Other study ID #: 1000025147
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Asthma
• Avitaminosis
• Respiratory Tract Infections

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