跳至主要内容
临床试验/NCT02680769
NCT02680769Unknown不适用

Daily Supplementation of Magnesium Citrate in Moderate-severe Chronic Obstructive Pulmonary Disease: a Randomized, Controlled, Double-blind Trial

University of Padova2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2016年3月1日最近更新:
适应症

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

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

研究者

发起方
University of Padova
申办方类型
Other
责任方
Sponsor

研究点 (2)

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