Chronic Obstructive Pulmonary Disease (COPD)Phase 1/2NCT00500864
Magnesium Loading in Chronic Obstructive Pulmonary Disease
A Phase 1/2 study testing Magnesium Sulfate 2 grams in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Magnesium Sulfate 2 grams
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2004to Nov 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis according GOLD criteria
- Men between 45 and 80 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900
About this study
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.
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.
Read the 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.
- Being tested
- Magnesium Sulfate 2 grams
- Keywords
- COPD, Magnesium, Pulmonary function, Exercise Physiology
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate 2 gramsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of forced vital capacity (FVC), forced expiratory volume (FEV1), functional residual capacity (FRC),maximal respiratory pressures,maximal oxygen consumption and maximal work load.
Measured: 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.
Measured: Immediatly after the end of IV infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startAug 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- José B Martinez, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500864
- Sponsor's protocol ID
- HCFMRP8518/2003
- Status last verified
- Jun 2008
- First submitted
- 12 Jul 2007
- Last updated
- 2 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22760901
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00500864
- Acronym / sponsor ID
- HCFMRP8518/2003
- Keywords
- COPD, Magnesium, Pulmonary function, Exercise Physiology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD diagnosis according GOLD criteria
- Men between 45 and 80 years old
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate 2 grams | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2008.
- Derived from this study: PubMed 22760901Amaral 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.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 3
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José B Martinez, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Magnesium Sulfate 2 grams in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2008.