Daily Supplementation of Magnesium Citrate in Moderate-severe Chronic Obstructive Pulmonary Disease: a Randomized, Controlled, Double-blind Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in forced expiratory volume in the 1st second between baseline and 6 months
研究概览
简要总结
Magnesium (Mg) is involved in several pathways that could be affected in chronic obstructive pulmonary diseases (COPDs), namely in the contractility and excitability of neuro-muscolar endothelial cells and low-grade inflammation, a typical state of COPD. In this sense, several randomized controlled trials (RCTs) confirmed a positive role of Mg in asthma since long-period oral supplementation of Mg leads to a clinical and spirometric improvement.
Subjects with COPD seem to have a reduced bioavailability of Mg probably due to the use of drugs that may increase Mg losses (e.g. beta-agonists and cortisones), to a reduced dietary Mg intake, and heavy smoking. A recent study showed that the administration of endovenous or aerosol Mg sulphate with beta-agonists acutely improve maximum expiratory flow during COPD relapses as well as the prolonged treatment with endovenous sulphate Mg led to a reduction in pulmonary hyperinflation and increase in muscles involved in respiration, with a consequent clinical and instrumental improvement.
These evidences suggest that a chronic supplementation with Mg could improve COPD in clinical and instrumental parameters, but, at the best of our knowledge, no study was available in this sense.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years).
- •Moderate-severe COPD (FEV1 between 30-80% of theorical values).
排除标准
- •Already taking magnesium or calcium supplementations.
- •Severe renal (creatinine clearance< 30 ml/min) or hepatic decline or presence of other co-morbidities interfering with outcomes (e.g. dementia).
- •Hypermagnesemia (serum Mg>1.85 mmol/L).
结局指标
主要结局
Change in forced expiratory volume in the 1st second between baseline and 6 months
时间窗: 0-3-6 months
次要结局
未报告次要终点
