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

R

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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