Magnesium Loading in Chronic Obstructive Pulmonary Disease
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.
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2004
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 12, 2007
CompletedFirst Posted
Study publicly available on registry
July 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedJuly 2, 2008
June 1, 2008
3.3 years
July 12, 2007
June 27, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurements of forced vital capacity (FVC), forced expiratory volume (FEV1), functional residual capacity (FRC),maximal respiratory pressures,maximal oxygen consumption and maximal work load.
Immediatly after the end of IV infusion
Secondary Outcomes (1)
Arterial blood gases at rest, heart rate and mean arterial blood pressure. Degree of desaturation during maximal exercise.
Immediatly after the end of IV infusion
Interventions
Eligibility Criteria
You may qualify if:
- COPD diagnosis according GOLD criteria
- Men between 45 and 80 years old
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900, Brazil
Related Publications (1)
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.
PMID: 22760901DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José B Martinez, MD, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 12, 2007
First Posted
July 13, 2007
Study Start
August 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
July 2, 2008
Record last verified: 2008-06