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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578824
• Other study ID #: Vit D and asthma in VDRR CTIL
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: June 12, 2013
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 40 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Asthma
• Familial Hypophosphatemic Rickets
• Rickets
• Vitamin D Resistant Rickets

Intervention

Other:
• Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20

Locations

Country	Name	City	State
Israel	RAMBAM Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metacholine Challenge Test	As assessed by methacholine challenge test with determination of PC20.	participants will be followed for the duration of hospital visit, an average of 3 hours	Yes
Secondary	IgE	in peripheral Blood count	participants will be followed for the duration of hospital visit, an average of 3 hours	No
Secondary	CBC	in peripheral Blood count	participants will be followed for the duration of hospital visit, an average of 3 hours	No
Secondary	Fractional Exhaled NO	determination of exhaled NO in Exhaled breath	participants will be followed for the duration of hospital visit, an average of 3 hours	No
Secondary	skin tests for inhaled allergens		participants will be followed for the duration of hospital visit, an average of 3 hours	No
Secondary	Inhaled breath condensate		participants will be followed for the duration of hospital visit, an average of 3 hours	No
Secondary	C reactive protein	in peripheral Blood count	participants will be followed for the duration of hospital visit, an average of 3 hours	No
Secondary	25 OH vitamin D3	in peripheral Blood count	participants will be followed for the duration of hospital visit, an average of 3 hours	No