Magnesium Loading in Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dietary magnesium (Mg) intake has been shown to be independently related to lung function, airway reactivity, and respiratory symptoms in the general population. Inhaled Mg and IV Mg administration have been shown to promote bronchodilation and to improve lung function in asthmatic patients. Some studies have suggested that COPD patients exhibit decreased body levels of Mg. The purpose of the present study was to investigate the effects of acute IV Mg loading on parameters of respiratory function and maximal exercise capacity of stable COPD patients.The study hypothesis is that Mg administration will be associated to improvements on airflow and vasodilation leading to improvements of pulmonary function and exercise performance.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients are required to have a diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria.

This is a randomized, double-blind, placebo-controlled, cross-over study. Twenty five patients are going to be included. They are going to come to the laboratory to receive IV placebo or IV Mg sulfate at two distinct occasions about 48 hours apart. Half of the patients are going to receive Mg first and Placebo at the second day, while the other half are going to receive the treatments in an inverse order. Tests are going to be performed before and about 40 minutes after the IV infusions. Tests to be performed are: spirometry, arterial blood gases, Mg plasma level measurements, and a maximal exercise test protocol in cycloergometer.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COPD Magnesium Pulmonary function Exercise Physiology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnesium Sulfate 2 grams

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* COPD diagnosis according GOLD criteria
* Men between 45 and 80 years old

Exclusion Criteria

* History of asthma or atopy, renal failure, heart failure, arrhythmias or cardiac electrical disturbances, and other significant disease other than COPD.
* Individuals on chronic oral steroids, diuretics, or use of mineral supplementation.
* Locomotor impairment.

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

José B Martinez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

Amaral AF, Gallo L Jr, Vannucchi H, Crescencio JC, Vianna EO, Martinez JA. The effect of acute magnesium loading on the maximal exercise performance of stable chronic obstructive pulmonary disease patients. Clinics (Sao Paulo). 2012;67(6):615-22. doi: 10.6061/clinics/2012(06)12.

Reference Type DERIVED

PMID: 22760901 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HCFMRP8518/2003

Identifier Type: -

Identifier Source: org_study_id