The Effect of Vitamin D Replacement on Airway Reactivity, Allergy and Inflammatory Mediators in Exhaled Breath Condensate in Vitamin D Deficient Asthmatic Children

Study Overview
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Brief Summary
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Research Title: The effect of vitamin D replacement on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic children. Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions as an immunomodulator. Asthma disease involves inflammatory process in the lower respiratory tract and airway hyperreactivity. Aim: To assess the effect of Vitamin D replacement on airway reactivity, and allergy and inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic children. Design: Double blind placebo control prospective study comparing the effect of Vitamin D replacement and placebo on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in asthmatic pediatric population with vitamin D deficiency. Participant selection: The study group will consist of pediatric patients (age 6-18 years) followed and treated at the Pediatric Pulmonary Unit at the investigators hospital. Patients with mild-moderate asthma with low or insufficient vitamin D levels that are currently not receiving anti-inflammatory treatment will be recruited. Sample size: 60 participants in the two groups (30 receiving Vitamin D and 30 receiving placebo). Intervention: Vitamin D (14000 units) or placebo will be provided in a similar appearance preparation once weekly for 6 weeks between visit two and three. Three visits will be conducted. Each subject will undergo evaluation including a respiratory questionnaire (visit 1), methacholine challenge test with determination of PC20 (visit 1 or 2 and visit 3), exhaled nitric oxide (eNO) (visit 2, 3), and exhaled breath condensate (EBC) (visit 2,3). Venous blood will be analyzed for complete blood count + eosinophils (visit 1, 3), IGE levels (visit 1, 3), and Vitamin D levels (visit 1, 3). Prick skin test for inhaled allergens will be performed (visit 2, 3). Primary end point: Airway reactivity as assessed by methacholine challenge test. Secondary outcome parameters: All other parameters are the secondary end points.

Conditions
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Asthma, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D3 as BABY D3
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6-18 years Mild-moderate asthma No anti inflammatory treatment over the past 2 weeks Exclusion Criteria: Any Chronic Lung Disease Febrile Illness in last 2 weeks FEV1 < 65% in study day Bronchodilators over the past 24 hours prior to each study Participation in any other clinical studies over the past 4 weeks

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamin D<br>vitamin D deficient asthmatic patients receiving vitamin D supplement | Drug: Vitamin D3 as BABY D3<br>* drops, 70 drops (= 14000 units), once weekly for 6 weeks<br>|
| Placebo Comparator: placebo<br>vitamin D deficient asthmatic patients receiving placebo | Other: placebo<br>* drops, 70 placebo drops, once weekly for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metacholine Challenge Test | As assessed by methacholine challenge test with determination of PC20. | study visit 1,3 (6wks- 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGE | in peripheral Blood count | study visit 1,3 (6wks- 3 months) | 
| CBC | in peripheral Blood count | study visit 1,3 (6wks- 3 months) | 
| Fractional Exhaled NO | determination of exhaled NO in Exhaled breath | visit study 2,3 (6wks) | 
| skin tests for inhaled allergens |  | visit study 2,3 (6wks) | 
| Exhaled breath condensate | R-tubes test | visit study 2,3 (6wks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Vitamin D, airway reactivity, metacholine challenge test