Clinical trial NCT01578824: Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
Official title: Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Vitamin D Resistant Rickets
Keywords: Rickets
Vitamin D
airway hyperreactivity
Exhaled breath condensate
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 26
Sex: ALL
Minimum age (years): 3
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metacholine Challenge Test
timeFrame: participants will be followed for the duration of hospital visit, an average of 3 hours
Secondary outcomes:
measure: IgE
timeFrame: participants will be followed for the duration of hospital visit, an average of 3 hours
measure: CBC
timeFrame: participants will be followed for the duration of hospital visit, an average of 3 hours
measure: Fractional Exhaled NO
timeFrame: participants will be followed for the duration of hospital visit, an average of 3 hours
measure: skin tests for inhaled allergens
timeFrame: participants will be followed for the duration of hospital visit, an average of 3 hours
measure: Inhaled breath condensate
timeFrame: participants will be followed for the duration of hospital visit, an average of 3 hours
measure: C reactive protein
timeFrame: participants will be followed for the duration of hospital visit, an average of 3 hours
measure: 25 OH vitamin D3
timeFrame: participants will be followed for the duration of hospital visit, an average of 3 hours
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM Health Care Campus
Study officials:
affiliation: Rambam MC
name: Lea Bentur, Prof.
role: PRINCIPAL_INVESTIGATOR
References: