Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
NCT ID: NCT01578824
Last Updated: 2013-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2011-03-31
2012-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Healthy Control
Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Vitamin D resistant Rickets
Vitamin D resistant Rickets patients
Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Interventions
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Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 3 - 40 years
Exclusion Criteria
* 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
3 Years
40 Years
ALL
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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Lea Bentur, Prof.
Role: PRINCIPAL_INVESTIGATOR
Rambam MC
Locations
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RAMBAM Health Care Campus
Haifa, Israel, Israel
Countries
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Other Identifiers
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Vit D and asthma in VDRR CTIL
Identifier Type: -
Identifier Source: org_study_id
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