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Magnesium Loading in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500864
First Posted: July 13, 2007
Last Update Posted: July 2, 2008
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.
Information provided by:
University of Sao Paulo
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Magnesium Sulfate 2 grams Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Acute Intravenous Magnesium Loading on Pulmonary Function Parameters and Maximal Exercise Capacity of Patients With Chronic Obstructive Pulmonary Disease in Stable Clinical Conditions.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Measurements of forced vital capacity (FVC), forced expiratory volume (FEV1), functional residual capacity (FRC),maximal respiratory pressures,maximal oxygen consumption and maximal work load. [ Time Frame: Immediatly after the end of IV infusion ]

Secondary Outcome Measures:
  • Arterial blood gases at rest, heart rate and mean arterial blood pressure. Degree of desaturation during maximal exercise. [ Time Frame: Immediatly after the end of IV infusion ]

Enrollment: 24
Study Start Date: August 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT00500864


Locations
Brazil
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, SP, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: José B Martinez, MD, PhD University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00500864     History of Changes
Other Study ID Numbers: HCFMRP8518/2003
First Submitted: July 12, 2007
First Posted: July 13, 2007
Last Update Posted: July 2, 2008
Last Verified: June 2008

Keywords provided by University of Sao Paulo:
COPD
Magnesium
Pulmonary function
Exercise Physiology

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents