The Effect of Vitamin D Replacement on Airway Reactivity, Allergy and Inflammatory Mediators in Exhaled Breath Condensate in Vitamin D Deficient Asthmatic Children
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
- Metacholine Challenge Test [ Time Frame: study visit 1,3 (6wks- 3 months) ]As assessed by methacholine challenge test with determination of PC20.
- IGE [ Time Frame: study visit 1,3 (6wks- 3 months) ]in peripheral Blood count
- CBC [ Time Frame: study visit 1,3 (6wks- 3 months) ]in peripheral Blood count
- Fractional Exhaled NO [ Time Frame: visit study 2,3 (6wks) ]determination of exhaled NO in Exhaled breath
- skin tests for inhaled allergens [ Time Frame: visit study 2,3 (6wks) ]
- Exhaled breath condensate [ Time Frame: visit study 2,3 (6wks) ]R-tubes test
|Study Start Date:||February 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Active Comparator: vitamin D
vitamin D deficient asthmatic patients receiving vitamin D supplement
Drug: Vitamin D3 as "BABY D3"
drops, 70 drops (= 14000 units), once weekly for 6 weeks
Placebo Comparator: placebo
vitamin D deficient asthmatic patients receiving placebo
drops, 70 placebo drops, once weekly for 6 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287455
|RAMBAM Health Care Campus|
|Haifa, Israel, 31096|
|Principal Investigator:||Lea Bentur, Prof.||Rambam Health Care Campus|