NCT01113151已完成不适用
Daily Magnesium-supplement With Mablet for Steroid-resistant, Severe Asthmatics
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Asthma control test (ACT)
研究概览
简要总结
The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.
The aim of this part of the project is to reveal possible beneficial effects of daily magnesium supplement for severe asthmatics, refractory to conventional treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe asthmatics, refractory to conventional treatment, including systemic steroid treatment; symptoms must be annual.
排除标准
- •Se-Mg > 2,00 mmol/L,
- •smoking cessation less than 1 year prior to study start,
- •major changes in eating habits within three months prior to study start and during the study period of approximately one year,
- •various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.
研究组 & 干预措施
Washout
No Intervention
Mablet
Active Comparator
干预措施: Mablet (Magnesium-supplement) (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Asthma control test (ACT)
时间窗: Two years
Questionnaire providing a level of disease control
次要结局
- EQ-5D(Two years)
- Spirometry(Two years)
- Reversibility testing(Two years)
- Diary(Two years)
- Adverse effects(Two years)
- Blood- and urine samples(Two years)
- Endogen NO in expiratory breath and Impulse Oscillometry.(Two years)
研究者
研究点 (1)
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