Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Magnesium Supplementation in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02680769
Recruitment Status : Unknown
Verified June 2016 by University of Padova.
Recruitment status was:  Recruiting
First Posted : February 12, 2016
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Dietary Supplement: 300 mg of citrate Mg Other: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daily Supplementation of Magnesium Citrate in Moderate-severe Chronic Obstructive Pulmonary Disease: a Randomized, Controlled, Double-blind Trial
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Magnesium
300 mg of citrate Mg/daily
Dietary Supplement: 300 mg of citrate Mg
This group will take an oral supplementation of 300 mg of citrate magnesium

Placebo Comparator: Placebo
placebo group
Other: Placebo
This group will take a placebo




Primary Outcome Measures :
  1. Change in forced expiratory volume in the 1st second between baseline and 6 months [ Time Frame: 0-3-6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680769


Contacts
Layout table for location contacts
Contact: Giuseppe Sergi, MD 00390498218492 giuseppe.sergi@unipd.it

Locations
Layout table for location information
Italy
University of Padova-Geriatrics Section Recruiting
Padova, PD, Italy, 35128
Contact: Nicola Veronese, MD    00390498218492    ilmannato@gmail.com   
Sponsors and Collaborators
University of Padova

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT02680769     History of Changes
Other Study ID Numbers: 3577
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action