Effect of Magnesium Supplementation in COPD

U

University of Padova

Status

Unknown

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Dietary Supplement: 300 mg of citrate Mg
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02680769
3577

Details and patient eligibility

About

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.

Enrollment

76 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

76 participants in 2 patient groups, including a placebo group

Magnesium
Experimental group
Description:
300 mg of citrate Mg/daily
Treatment:
Dietary Supplement: 300 mg of citrate Mg
Placebo
Placebo Comparator group
Description:
placebo group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Giuseppe Sergi, MD

Data sourced from clinicaltrials.gov

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