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临床试验/NCT01578824
NCT01578824已完成不适用

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

Rambam Health Care Campus2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Metacholine Challenge Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
3 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Vitamin D Resistent Rickets
  • Age between 3 - 40 years

排除标准

  • 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

结局指标

主要结局

Metacholine Challenge Test

时间窗: participants will be followed for the duration of hospital visit, an average of 3 hours

As assessed by methacholine challenge test with determination of PC20.

次要结局

  • IgE(participants will be followed for the duration of hospital visit, an average of 3 hours)
  • CBC(participants will be followed for the duration of hospital visit, an average of 3 hours)
  • Fractional Exhaled NO(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(participants will be followed for the duration of hospital visit, an average of 3 hours)
  • 25 OH vitamin D3(participants will be followed for the duration of hospital visit, an average of 3 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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