Effect of Magnesium Supplementation in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02680769
• Other study ID #: 3577
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2016
• Last updated: June 10, 2016
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: June 2016
• Source: University of Padova
• Contact: Giuseppe Sergi, MD
• Phone: 00390498218492
• Email: giuseppe.sergi[@]unipd.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• 300 mg of citrate Mg
This group will take an oral supplementation of 300 mg of citrate magnesium

Other:
• Placebo
This group will take a placebo

Locations

Country	Name	City	State
Italy	University of Padova-Geriatrics Section	Padova	PD

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Aziz HS, Blamoun AI, Shubair MK, Ismail MM, DeBari VA, Khan MA. Serum magnesium levels and acute exacerbation of chronic obstructive pulmonary disease: a retrospective study. Ann Clin Lab Sci. 2005 Autumn;35(4):423-7. — View Citation

Beasley R, Aldington S. Magnesium in the treatment of asthma. Curr Opin Allergy Clin Immunol. 2007 Feb;7(1):107-10. Review. — View Citation

Gontijo-Amaral C, Ribeiro MA, Gontijo LS, Condino-Neto A, Ribeiro JD. Oral magnesium supplementation in asthmatic children: a double-blind randomized placebo-controlled trial. Eur J Clin Nutr. 2007 Jan;61(1):54-60. Epub 2006 Jun 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in forced expiratory volume in the 1st second between baseline and 6 months		0-3-6 months	No