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

Rambam Health Care Campus

Status: Completed

Conditions: Asthma; Vitamin D Resistant Rickets

Treatments: Other: Methacholine Challenge Test

Study type: Interventional

Funder types: Other

Identifiers

NCT01578824

Vit D and asthma in VDRR CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 3 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Healthy Control

Active Comparator group

Treatment:

Other: Methacholine Challenge Test

Vitamin D resistant Rickets

Active Comparator group

Description:

Vitamin D resistant Rickets patients

Treatment:

Other: Methacholine Challenge Test