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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Vitamin D Resistant Rickets
• Intervention / Treatment: Other: Methacholine Challenge Test

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Healthy Control	Other: Methacholine Challenge Test; Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20; Other Names: Airway Hyperresponsiveness test
ACTIVE_COMPARATOR: Vitamin D resistant Rickets; Vitamin D resistant Rickets patients	Other: Methacholine Challenge Test; Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20; Other Names: Airway Hyperresponsiveness test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgE	in peripheral Blood count	participants will be followed for the duration of hospital visit, an average of 3 hours
CBC	in peripheral Blood count	participants will be followed for the duration of hospital visit, an average of 3 hours
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
skin tests for inhaled allergens		participants will be followed for the duration of hospital visit, an average of 3 hours
Inhaled breath condensate		participants will be followed for the duration of hospital visit, an average of 3 hours
C reactive protein	in peripheral Blood count	participants will be followed for the duration of hospital visit, an average of 3 hours
25 OH vitamin D3	in peripheral Blood count	participants will be followed for the duration of hospital visit, an average of 3 hours

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Lea Bentur, Prof., Rambam MC

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: April 15, 2012
• First Posted (ESTIMATE): April 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 13, 2013
• Last Update Submitted That Met QC Criteria: June 12, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Vitamin D; Rickets; Exhaled breath condensate; airway hyperreactivity
• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Kidney Diseases; Urologic Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Musculoskeletal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Bone Diseases; Metabolism, Inborn Errors; Bone Diseases, Metabolic; Renal Tubular Transport, Inborn Errors; Calcium Metabolism Disorders; Metal Metabolism, Inborn Errors; Phosphorus Metabolism Disorders; Vitamin D Deficiency; Hypophosphatemia, Familial; Hypophosphatemia; Asthma; Rickets; Familial Hypophosphatemic Rickets; Rickets, Hypophosphatemic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Respiratory System Agents; Miotics; Parasympathomimetics; Bronchoconstrictor Agents; Muscarinic Agonists; Methacholine Chloride
• Other Study ID Numbers: Vit D and asthma in VDRR CTIL