The Effect of Vitamin D Replacement on Airway Reactivity, Allergy and Inflammatory Mediators in Exhaled Breath Condensate in Vitamin D Deficient Asthmatic Children
- Conditions
- AsthmaVitamin D Deficiency
- Interventions
- Drug: Vitamin D3 as "BABY D3"Other: placebo
- Registration Number
- NCT01287455
- Lead Sponsor
- Rambam Health Care Campus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 6-18 years
- Mild-moderate asthma
- No anti inflammatory treatment over the past 2 weeks
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vitamin D Vitamin D3 as "BABY D3" vitamin D deficient asthmatic patients receiving vitamin D supplement placebo placebo vitamin D deficient asthmatic patients receiving placebo
- Primary Outcome Measures
Name Time Method Metacholine Challenge Test study visit 1,3 (6wks- 3 months) As assessed by methacholine challenge test with determination of PC20.
- Secondary Outcome Measures
Name Time Method IGE study visit 1,3 (6wks- 3 months) in peripheral Blood count
CBC study visit 1,3 (6wks- 3 months) in peripheral Blood count
Fractional Exhaled NO visit study 2,3 (6wks) determination of exhaled NO in Exhaled breath
skin tests for inhaled allergens visit study 2,3 (6wks) Exhaled breath condensate visit study 2,3 (6wks) R-tubes test
Trial Locations
- Locations (1)
RAMBAM Health Care Campus
🇮🇱Haifa, Israel