Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients
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| First Received Date ICMJE | November 9, 2011 | ||||
| Last Updated Date | June 12, 2013 | ||||
| Start Date ICMJE | March 2011 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Metacholine Challenge Test [ Time Frame: baseline ] [ Designated as safety issue: Yes ] As assessed by methacholine challenge test with determination of PC20. |
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| Change History | Complete list of historical versions of study NCT01578824 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients | ||||
| Official Title ICMJE | Assessment Of Vitamin D Role In The Pathogenesis Of Asthma In Vitamin D Resistent Patients | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Methacholine Challenge Test
Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
Other Name: Airway Hyperresponsiveness test |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 26 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01578824 | ||||
| Other Study ID Numbers ICMJE | Vit D and asthma in VDRR CTIL | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Rambam Health Care Campus | ||||
| Study Sponsor ICMJE | Rambam Health Care Campus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rambam Health Care Campus | ||||
| Verification Date | June 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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