DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers (DO IT)

• ClinicalTrials.gov Identifier: NCT01419262
• Recruitment Status: Completed
• First Posted: August 18, 2011
• Last Update Posted: June 14, 2019
• Sponsor: The Hospital for Sick Children
• Collaborators: Mount Sinai Hospital, Canada; Unity Health Toronto
• Information provided by (Responsible Party): Jonathon L Maguire, The Hospital for Sick Children

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Respiratory Tract Infections; Asthma; Avitaminosis	Drug: Vitamin D - Cholecalciferol 400 IU; Drug: Vitamin D3 - Cholecalciferol 2000 IU	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 703 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
• Study Start Date: September 2011
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Number of Laboratory confirmed upper respiratory tract infections [ Time Frame: Up to 8 months ]
   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 :

1. Number of parent reported upper respiratory tract infections [ Time Frame: Up to 8 months ]
   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.
2. Number of Asthma exacerbations [ Time Frame: Up to 8 months ]
   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).
3. Serum vitamin D level [ Time Frame: 5-8months ]
   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.
4. Direct and indirect economic costs associated with upper respiratory tract infections [ Time Frame: 16 months ]
   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.

Other Outcome Measures:

1. Body Mass index z-score [ Time Frame: Up to 8 months ]
   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.
2. Waist circumference z-score [ Time Frame: Up to 8 months ]
   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.
3. Serum Lipids [ Time Frame: Up to 8 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 5 Years (Child)
• Sexes Eligible for Study: All
• 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

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

Unity Health Toronto

Investigators

• Principal Investigator: Jonathon L Maguire, MD, MSc; St. Michael's Hospital, Toronto, Ontario, Canada

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Peña-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12:CD012875. doi: 10.1002/14651858.CD012875.pub2.

Aglipay M, Birken CS, Parkin PC, Loeb MB, Thorpe K, Chen Y, Laupacis A, Mamdani M, Macarthur C, Hoch JS, Mazzulli T, Maguire JL; TARGet Kids! Collaboration. Effect of High-Dose vs Standard-Dose Wintertime Vitamin D Supplementation on Viral Upper Respiratory Tract Infections in Young Healthy Children. JAMA. 2017 Jul 18;318(3):245-254. doi: 10.1001/jama.2017.8708.

• Responsible Party: Jonathon L Maguire, Physician/ Principal Investigator, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT01419262
• Other Study ID Numbers: 1000025147
• First Posted: August 18, 2011
• Last Update Posted: June 14, 2019
• Last Verified: June 2019

Keywords provided by Jonathon L Maguire, 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; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents