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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01578824
First received: November 9, 2011
Last updated: June 12, 2013
Last verified: June 2013

November 9, 2011
June 12, 2013
March 2011
April 2012   (final data collection date for primary outcome measure)
Metacholine Challenge Test [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: Yes ]
As assessed by methacholine challenge test with determination of PC20.
Metacholine Challenge Test [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
As assessed by methacholine challenge test with determination of PC20.
Complete list of historical versions of study NCT01578824 on ClinicalTrials.gov Archive Site
  • IgE [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    in peripheral Blood count
  • CBC [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    in peripheral Blood count
  • Fractional Exhaled NO [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    determination of exhaled NO in Exhaled breath
  • skin tests for inhaled allergens [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
  • Inhaled breath condensate [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
  • C reactive protein [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    in peripheral Blood count
  • 25 OH vitamin D3 [ Time Frame: participants will be followed for the duration of hospital visit, an average of 3 hours ] [ Designated as safety issue: No ]
    in peripheral Blood count
  • IgE [ Time Frame: baseline ] [ Designated as safety issue: No ]
    in peripheral Blood count
  • CBC [ Time Frame: baseline ] [ Designated as safety issue: No ]
    in peripheral Blood count
  • Fractional Exhaled NO [ Time Frame: baseline ] [ Designated as safety issue: No ]
    determination of exhaled NO in Exhaled breath
  • skin tests for inhaled allergens [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Inhaled breath condensate [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • C reactive protein [ Time Frame: baseline ] [ Designated as safety issue: No ]
    in peripheral Blood count
  • 25 OH vitamin D3 [ Time Frame: baseline ] [ Designated as safety issue: No ]
    in peripheral Blood count
Not Provided
Not Provided
 
Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Asthma
  • Vitamin D Resistant Rickets
Other: Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Other Name: Airway Hyperresponsiveness test
  • Active Comparator: Healthy Control
    Intervention: Other: Methacholine Challenge Test
  • Active Comparator: Vitamin D resistant Rickets
    Vitamin D resistant Rickets patients
    Intervention: Other: Methacholine Challenge Test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
3 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01578824
Vit D and asthma in VDRR CTIL
Yes
Rambam Health Care Campus
Rambam Health Care Campus
Not Provided
Principal Investigator: Lea Bentur, Prof. Rambam MC
Rambam Health Care Campus
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP