Clinical Trial: Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
Brief 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 Summary:
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.
Sponsor: Rambam Health Care Campus
Current Primary Outcome: Metacholine Challenge Test [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ]
Original Primary Outcome: Metacholine Challenge Test [ Time Frame: baseline ]
Current Secondary Outcome:
- IgE [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ]in peripheral Blood count
- CBC [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ]in peripheral Blood count
- Fractional Exhaled NO [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ]determination of exhaled NO in Exhaled breath
- skin tests for inhaled allergens [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ]
- Inhaled breath condensate [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ]
- C reactive protein [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ]in peripheral Blood count
- 25 OH vitamin D3 [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ]in peripheral Blood count
Original Secondary Outcome:
- IgE [ Time Frame: baseline ]in peripheral Blood count
- CBC [ Time Frame: baseline ]in peripheral Blood count
- Fractional Exhaled NO [ Time Frame: baseline ]determination of exhaled NO in Exhaled breath
- skin tests for inhaled allergens [ Time Frame: baseline ]
- Inhaled breath condensate [ Time Frame: baseline ]
- C reactive protein [ Time Frame: baseline ]in peripheral Blood count
- 25 OH vitamin D3 [ Time Frame: baseline ]in peripheral Blood count
Information By: Rambam Health Care Campus
Dates:
Date Received: November 9, 2011
Date Started: March 2011
Date Completion:
Last Updated: June 12, 2013
Last Verified: June 2013