Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500864
Status:
COMPLETED
Last Update Posted:
2008-07-02
First Post:
2007-07-12
Brief Title:
Magnesium Loading in Chronic Obstructive Pulmonary Disease
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientsThe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None