Vitamin D Deficiency and Asthma Exacerbation (AVD)
2016年1月18日 更新者：Caterina Bucca、University of Turin, Italy
Effect of Vitamin D Repletion on Asthma Exacerbation
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
119
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
12年 至 80年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Acute exacerbation in the last month and treatment with vitamins and dietary supplements in the last year.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：asthma severity and disease exacerbation
intramuscular cholecalciferol 100,000 IU, followed by oral cholecalciferol 5000 IU weekly plus 400 IU daily for one year
|
Inhaled corticosteroids and long-acting beta-agonists, salbutamol
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Relationship between serum 25-hydroxide (OH) vitamin D level and asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)
大体时间：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
|
one year
|
|
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)
大体时间：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
|
One year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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%)
大体时间：one year
|
119 consecutive asthmatic patients underwent serum vitamin D (25-OHD, ng/ml) and lung function assessment.
Their medical records were retrospectively reviewed, to gain information on lung function tests (forced expiratory volume in 1 second, FEV1, and vital capacity, VC) during the 12 months preceding study entry.
The relationship between baseline 25-OH vitamin D and airway obstruction (FEV1 and FEV1/VC%) was investigated
|
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%)
大体时间：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).
Lung function tests (FEV1, VC and FEV1/VC%) were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency
|
one year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Caterina B Bucca, MD、Dept. Medical Science, University of Turin
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Malinovschi A, Masoero M, Bellocchia M, Ciuffreda A, Solidoro P, Mattei A, Mercante L, Heffler E, Rolla G, Bucca C. Severe vitamin D deficiency is associated with frequent exacerbations and hospitalization in COPD patients. Respir Res. 2014 Dec 13;15(1):131. doi: 10.1186/s12931-014-0131-0.
- Masoero M, Bellocchia M, Ciuffreda A, Ricciardolo FL, Rolla G, Bucca C. Laryngeal spasm mimicking asthma and vitamin d deficiency. Allergy Asthma Immunol Res. 2014 May;6(3):267-9. doi: 10.4168/aair.2014.6.3.267. Epub 2014 Jan 14.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年10月1日
初级完成 (实际的)
2013年3月1日
研究完成 (实际的)
2014年3月1日
研究注册日期
首次提交
2015年12月21日
首先提交符合 QC 标准的
2016年1月18日
首次发布 (估计)
2016年1月22日
研究记录更新
最后更新发布 (估计)
2016年1月22日
上次提交的符合 QC 标准的更新
2016年1月18日
最后验证
2016年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.