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| ID | Type | Description | Link |
|---|---|---|---|
| 12140 | Other Grant/Funding Number | Thrasher Research Fund |
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Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | bolus placebo given in a 2ml dose by mouth at baseline. This group receives daily vitamin D supplement by mouth for the 6 month study (400IU cholecalciferol per day). |
|
| Vitamin D | Active Comparator | Vitamin D (100,000IU) bolus in a 2ml dose by mouth given at baseline. This group receives a daily vitamin D supplement by mouth for 6 months (400IU cholecalciferol per day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | 100,000IU cholecalciferol given in a 2ml dose by mouth at baseline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum Vitamin D | mean change in serum vitamin D from baseline to 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| adequate serum vitamin D | difference in the proportion of children with serum vitamin D ≥75nmol/L at 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| exacerbations requiring oral corticosteroids | number of patients with one or more exacerbations requiring oral steroids, as documented by pharmacy dispensation records and medical records | 6 months |
| number of viral infections |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francine M Ducharme | St. Justine's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| 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. | |
| 27456232 | Derived | Jensen ME, Mailhot G, Alos N, Rousseau E, White JH, Khamessan A, Ducharme FM. Vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomised controlled trial. Trials. 2016 Jul 26;17(1):353. doi: 10.1186/s13063-016-1483-1. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| daily vitamin D supplement | Dietary Supplement | Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day. |
|
|
| Placebo | Other | placebo given in a 2ml dose by mouth at baseline. |
|
number of patients/person-month of observation documented two days
| 6 months |
| Hypercalciuria | urinary calcium: creatinine ratio >1.25 (1-2 years) and >1 (2-5 years) mmol/mmol | any point during the 6 months |
| Cytokine/ chemokine profile | change in serum cytokine/ chemokine profile from baseline to 10 days post-bolus dose | 10 days |
| duration of viral infections | number of days with respiratory tract symptoms as reported on the parent completed Canadian Acute Respiratory Illness & Flu Scale | in the event of a cold during the 6 months |
| severity of exacerbations |
| in the event of an exacberbation during the 6 months |
| duration of exacerbations | Number of days with asthma symptoms as reported on the parent-reported 'Asthma Flare-Up Diary for Young Children' | in the event of an exacerbation during the 6 months |
| participant retention | percentage of patients retained until 6 months after randomization | 6 months |
| protocol adherence |
| 6 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007239 | Infections |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |