Trial of Vitamin D3 Supplementation in Paediatric Asthma

Study Overview
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Brief Summary
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Epidemiological and observational studies have linked vitamin D deficiency with increased asthma/allergy incidence . Vitamin D insufficiency (<75nmol/L) has been associated with increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and allergy and asthma appears to be stronger in children than adults, with some even suggesting that childhood asthma may may be caused by VDD.

Detailed Description
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Asthmatic children will be recruited in winter. After baseline testing, children will be randomized to take 2,000iu vitamin D or placebo daily for 15 weeks. After the 15 weeks, testing will be repeated. Tests involve blood draws, questionnaires and breathing tests.

Official Title
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Randomized, Double-blind, Placebo Controlled Trial of Vitamin D3 Supplementation on Clinical, and Subjective Symptoms of Paediatric Asthma

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: VItamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous clinical diagnosis of asthma Ability to perform pulmonary function tests Established on anti-asthmatic pharmacotherapy with no expected change Exclusion Criteria: Use of medications that influence vitamin D metabolism or absorption Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>2,000iu vitamin D3 per day for 15 weeks | Dietary Supplement: Placebo<br>* Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.<br>Dietary Supplement: VItamin D3<br>* Soft gel capsules will contain 2,000IU vitamin D.<br>|
| Placebo Comparator: Placebo<br>An identical placebo capsule daily for 15 weeks. | Dietary Supplement: Placebo<br>* Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paediatic Asthma Control Test (P-ACT) |  | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Initiative for Asthma Score |  | 15 weeks | 
| Pulmonary function | FEV1, FVC, FEV1:FVC | 15 weeks | 
| Height velocity | Rate of change in height | 15 weeks | 
| Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP. |  | 15 weeks | 
| Mini paediatric asthma quality of life questionnaire |  | 15 weeks | 
| Asthma Diary | A 13 item diary to be filled out weekly by parents/gaurdians. | 15 weeks |