Effect of Vitamin D Repletion on Asthma Exacerbation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 主要终点
- Relationship between serum 25-hydroxide (OH) vitamin D level and asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
研究概览
简要总结
The study aim is in two phases. First phase: to evaluate the influence of vitamin D deficiency on asthma severity, degree of airway obstruction and frequency of asthma exacerbations. Second phase: to evaluate if in patients with vitamin D deficiency (25-OH vitamin D levels below 20 ng/ml), vitamin D supplementation decreases the number of disease exacerbations.
详细描述
The first phase of the study consisted of a cross-sectional examination of a cohort of 119 asthmatic patients, who had at least one year regular follow-up in our respiratory clinic, and were not receiving any vitamin D supplementation.
In the second phase patients with vitamin D deficiency (25-OH D values below 20 ng/ml), were recruited in a one year longitudinal study, during which they received vitamin D supplementation. The study started and ended in late autumn-winter season when, at our latitude, sun exposure is lowest. Symptoms, spirometry and number of exacerbations were recorded during both study phases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the consecutive patients with bronchial asthma of any severity, who presented for a scheduled visit at our Respiratory Clinic during the period October 2012-March 2013 and who had at least one year regular follow-up every three months
排除标准
- •Acute exacerbation in the last month and treatment with vitamins and dietary supplements in the last year.
研究组 & 干预措施
asthma severity and disease exacerbation
intramuscular cholecalciferol 100,000 IU, followed by oral cholecalciferol 5000 IU weekly plus 400 IU daily for one year
干预措施: oral cholecalciferol (Drug)
结局指标
主要结局
Relationship between serum 25-hydroxide (OH) vitamin D level and asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
时间窗: one year
119 consecutive asthmatic patients underwent serum vitamin D (25-OHD) and lung function assessment. Their medical records were retrospectively reviewed, to gain information on disease exacerbations during the 12 months preceding study entry. The relationship between baseline 25-OH vitamin D and number of exacerbation was investigated
Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
时间窗: One year
55 asthmatic patients with 25-OH vitamin D below 20 ng/ml underwent supplementation with cholecalciferol for one year (intramuscular 100,000 IU, followed by oral 5000 IU weekly plus 400 IU daily for one year). Number of exacerbations were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency
次要结局
- Relationship between serum 25-OH vitamin D level and airway obstruction (evaluated by spirometry: one second forced expiratory volume, FEV1 l/sec, vital capacity (VC) and FEV1/VC%)(one year)
- Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on airway obstruction ( FEV1 l/sec, FEV1/VC%)(one year)
研究者
Caterina Bucca
Professor of Respiratory Medicine
University of Turin, Italy