The Effect of Vitamin D Replacement on Airway Reactivity, Allergy and Inflammatory Mediators in Exhaled Breath Condensate in Vitamin D Deficient Asthmatic Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Metacholine Challenge Test
研究概览
简要总结
Research Title: The effect of vitamin D replacement on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic children.
Introduction: Vitamin D seems to play a role in allergic and asthmatic reactions as an immunomodulator. Asthma disease involves inflammatory process in the lower respiratory tract and airway hyperreactivity.
Aim: To assess the effect of Vitamin D replacement on airway reactivity, and allergy and inflammatory mediators in exhaled breath condensate in vitamin D deficient asthmatic children.
Design: Double blind placebo control prospective study comparing the effect of Vitamin D replacement and placebo on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in asthmatic pediatric population with vitamin D deficiency.
Participant selection: The study group will consist of pediatric patients (age 6-18 years) followed and treated at the Pediatric Pulmonary Unit at the investigators hospital.
Patients with mild-moderate asthma with low or insufficient vitamin D levels that are currently not receiving anti-inflammatory treatment will be recruited.
Sample size: 60 participants in the two groups (30 receiving Vitamin D and 30 receiving placebo).
Intervention: Vitamin D (14000 units) or placebo will be provided in a similar appearance preparation once weekly for 6 weeks between visit two and three.
Three visits will be conducted. Each subject will undergo evaluation including a respiratory questionnaire (visit 1), methacholine challenge test with determination of PC20 (visit 1 or 2 and visit 3), exhaled nitric oxide (eNO) (visit 2, 3), and exhaled breath condensate (EBC) (visit 2,3). Venous blood will be analyzed for complete blood count + eosinophils (visit 1, 3), IGE levels (visit 1, 3), and Vitamin D levels (visit 1, 3). Prick skin test for inhaled allergens will be performed (visit 2, 3).
Primary end point: Airway reactivity as assessed by methacholine challenge test.
Secondary outcome parameters: All other parameters are the secondary end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-18 years
- •Mild-moderate asthma
- •No anti inflammatory treatment over the past 2 weeks
排除标准
- •Any Chronic Lung Disease
- •Febrile Illness in last 2 weeks
- •FEV1 < 65% in study day
- •Bronchodilators over the past 24 hours prior to each study
- •Participation in any other clinical studies over the past 4 weeks
研究组 & 干预措施
vitamin D
vitamin D deficient asthmatic patients receiving vitamin D supplement
干预措施: Vitamin D3 as "BABY D3" (Drug)
placebo
vitamin D deficient asthmatic patients receiving placebo
干预措施: placebo (Other)
结局指标
主要结局
Metacholine Challenge Test
时间窗: study visit 1,3 (6wks- 3 months)
As assessed by methacholine challenge test with determination of PC20.
次要结局
- IGE(study visit 1,3 (6wks- 3 months))
- CBC(study visit 1,3 (6wks- 3 months))
- Fractional Exhaled NO(visit study 2,3 (6wks))
- skin tests for inhaled allergens(visit study 2,3 (6wks))
- Exhaled breath condensate(visit study 2,3 (6wks))