Effect of Magnesium Supplementation in COPD

Not Applicable

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Dietary Supplement: 300 mg of citrate Mg; Other: Placebo

• Registration Number: NCT02680769
• Lead Sponsor: University of Padova

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-12
• Study Start: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-10
• Last Update Posted: 2016-06-13
• Primary Completion: 2018-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Adults (>18 years).
• Moderate-severe COPD (FEV1 between 30-80% of theorical values).

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium	300 mg of citrate Mg	300 mg of citrate Mg/daily
Placebo	Placebo	placebo group

Primary Outcome Measures

Name	Time	Method
Change in forced expiratory volume in the 1st second between baseline and 6 months	0-3-6 months

Trial Locations

Locations (1)

University of Padova-Geriatrics Section; 🇮🇹 Padova, PD, Italy