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

Primary Purpose

Asthma, Vitamin D Resistant Rickets

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Methacholine Challenge Test
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Asthma focused on measuring Rickets, Vitamin D, airway hyperreactivity, Exhaled breath condensate

Eligibility Criteria

3 Years - 40 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • RAMBAM Health Care Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy Control

Vitamin D resistant Rickets

Arm Description

Vitamin D resistant Rickets patients

Outcomes

Primary Outcome Measures

Metacholine Challenge Test
As assessed by methacholine challenge test with determination of PC20.

Secondary Outcome Measures

IgE
in peripheral Blood count
CBC
in peripheral Blood count
Fractional Exhaled NO
determination of exhaled NO in Exhaled breath
skin tests for inhaled allergens
Inhaled breath condensate
C reactive protein
in peripheral Blood count
25 OH vitamin D3
in peripheral Blood count

Full Information

First Posted
November 9, 2011
Last Updated
June 12, 2013
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01578824
Brief Title
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

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Vitamin D Resistant Rickets
Keywords
Rickets, Vitamin D, airway hyperreactivity, Exhaled breath condensate

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Control
Arm Type
Active Comparator
Arm Title
Vitamin D resistant Rickets
Arm Type
Active Comparator
Arm Description
Vitamin D resistant Rickets patients
Intervention Type
Other
Intervention Name(s)
Methacholine Challenge Test
Other Intervention Name(s)
Airway Hyperresponsiveness test
Intervention Description
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Primary Outcome Measure Information:
Title
Metacholine Challenge Test
Description
As assessed by methacholine challenge test with determination of PC20.
Time Frame
participants will be followed for the duration of hospital visit, an average of 3 hours
Secondary Outcome Measure Information:
Title
IgE
Description
in peripheral Blood count
Time Frame
participants will be followed for the duration of hospital visit, an average of 3 hours
Title
CBC
Description
in peripheral Blood count
Time Frame
participants will be followed for the duration of hospital visit, an average of 3 hours
Title
Fractional Exhaled NO
Description
determination of exhaled NO in Exhaled breath
Time Frame
participants will be followed for the duration of hospital visit, an average of 3 hours
Title
skin tests for inhaled allergens
Time Frame
participants will be followed for the duration of hospital visit, an average of 3 hours
Title
Inhaled breath condensate
Time Frame
participants will be followed for the duration of hospital visit, an average of 3 hours
Title
C reactive protein
Description
in peripheral Blood count
Time Frame
participants will be followed for the duration of hospital visit, an average of 3 hours
Title
25 OH vitamin D3
Description
in peripheral Blood count
Time Frame
participants will be followed for the duration of hospital visit, an average of 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lea Bentur, Prof.
Organizational Affiliation
Rambam MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
RAMBAM Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

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

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