NCT01578824

Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 3 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets. Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in a prospective study evaluating patients with vitamin D resistant rickets and in healthy controls. Sample size: 40 participants in the two groups. Primary end point: Airway reactivity as assessed by methacholine challenge test. Secondary outcome parameters: All other parameters are the secondary end points.

Detailed description

Research Title: Evaluation of airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D resistant rickets. Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions. Vitamin D resistant rickets patients lack vitamin D receptors and cannot absorb vitamin D. Aim: To assess the effect of absence of vitamin D receptors on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate. Design: Prospective study evaluating these parameters in patients with vitamin D resistant rickets and in healthy controls. Participant selection: The study group will consist of vitamin D resistant rickets patients followed and treated at the Pediatric Endocrinology Department at our hospital. The study group will be compared to an age- and sex-matched healthy control group that had a negative methacholine challenge test. Sample size: 40 participants in the two groups. Intervention: Each subject will undergo evaluation including a respiratory questionnaire, pulmonary function tests, methacholine challenge test with determination of PC20, exhaled nitric oxide (eNO), and exhaled breath condensate (EBC). Venous blood will be analyzed for complete blood count + eosinophils, IGE levels, and Vitamin D levels. Prick skin test for inhaled allergens will be performed. All measurements will be evaluated in a single 3 hour visit, with no follow up study visits. Primary end point: Airway reactivity as assessed by methacholine challenge test. Secondary outcome parameters: All other parameters are the secondary end points.

Conditions

• Asthma
• Vitamin D Resistant Rickets

Interventions

Type	Name	Description
OTHER	Methacholine Challenge Test	Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-04-01
• Completion: 2012-12-01
• First posted: 2012-04-17
• Last updated: 2013-06-13

Locations

1 site across 1 country: Israel