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| Name | Class |
|---|---|
| Mount Sinai Hospital, Canada | OTHER |
| Unity Health Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2000 IU per day vitamin D | Experimental |
| |
| 400 IU per day vitamin D | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D - Cholecalciferol 400 IU | Drug | One drop per day (liquid), 400 IU, 4 to 9 months depending on date of enrollment and date of follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathon L Maguire, MD, MSc | St. Michael's Hospital, Toronto, Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada | ||
| Hospital for Sick Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33305842 | Derived | Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-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(12):CD012875. doi: 10.1002/14651858.CD012875.pub2. | |
| 28719693 | Derived | 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. |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D001249 | Asthma |
| D001361 | Avitaminosis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Vitamin D3 - Cholecalciferol 2000 IU | Drug | One drop per day (liquid), 2000 IU, 4 to 9 months depending on date of enrollment and date of follow-up |
|
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Toronto |
| Ontario |
| M5G 1X8 |
| Canada |
| D008171 |
| Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |