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Magnesium Loading in Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Magnesium Sulfate 2 grams
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Magnesium, Pulmonary function, Exercise Physiology

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital das Clínicas de Ribeirão Preto

Outcomes

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.

Secondary Outcome Measures

Arterial blood gases at rest, heart rate and mean arterial blood pressure. Degree of desaturation during maximal exercise.

Full Information

First Posted
July 12, 2007
Last Updated
June 27, 2008
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00500864
Brief Title
Magnesium Loading in Chronic Obstructive Pulmonary Disease
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Magnesium, Pulmonary function, Exercise Physiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate 2 grams
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José B Martinez, MD, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas de Ribeirão Preto
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22760901
Citation
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.
Results Reference
derived

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Magnesium Loading in Chronic Obstructive Pulmonary Disease

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