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

Not Applicable

Completed

• Conditions: Asthma; Vitamin D Resistant Rickets
• Interventions: Other: Methacholine Challenge Test

• Registration Number: NCT01578824
• Lead Sponsor: Rambam Health Care Campus

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 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-11-09
• Primary Completion: 2012-04
• Study First Submitted QC: 2012-04-15
• Study First Posted: 2012-04-17
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-12
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Vitamin D Resistent Rickets
• Age between 3 - 40 years

Exclusion Criteria

• Any Chronic Lung Disease
• Febrile Illness in last 2 weeks
• Inhaled Corticosteroids over the past 2 weeks
• Bronchodilators over the past 24 hours
• Participation in any other clinical studies over the past 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Control	Methacholine Challenge Test	-
Vitamin D resistant Rickets	Methacholine Challenge Test	Vitamin D resistant Rickets patients

Primary Outcome Measures

Name	Time	Method
Metacholine Challenge Test	participants will be followed for the duration of hospital visit, an average of 3 hours	As assessed by methacholine challenge test with determination of PC20.

Secondary Outcome Measures

Name	Time	Method
C reactive protein	participants will be followed for the duration of hospital visit, an average of 3 hours	in peripheral Blood count
IgE	participants will be followed for the duration of hospital visit, an average of 3 hours	in peripheral Blood count
CBC	participants will be followed for the duration of hospital visit, an average of 3 hours	in peripheral Blood count
Fractional Exhaled NO	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	participants will be followed for the duration of hospital visit, an average of 3 hours
Inhaled breath condensate	participants will be followed for the duration of hospital visit, an average of 3 hours
25 OH vitamin D3	participants will be followed for the duration of hospital visit, an average of 3 hours	in peripheral Blood count

Trial Locations

Locations (1)

RAMBAM Health Care Campus; 🇮🇱 Haifa, Israel