Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease

September 3, 2013 updated by: University of Aarhus

Daily Mablet-treatment of Patients With COPD

The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.

The aim of this part of the project is to study the effect of a daily magnesium supplement for COPD-patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Research Dept. of Respiratory Medicine, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COPD-patients, grade moderate-severe (FEV1 30-80 % of expected. FEV1/FVC < 0,7).

Exclusion Criteria:

  • Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, submission to hospital within the last two years, submission to hospital with exacerbation during the study period, major changes in eating habits within three months prior to study start and during the study period of approx.one year various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
3 tablets of placebo daily for 12 weeks
No Intervention: Washout
Active Comparator: Mablet
Dietary supplement: Magnesium supplement (magnesium hydroxide/ -oxide)
3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
Other Names:
  • Mablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D
Time Frame: Two years
Questionnaire providing a degree of quality of life
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry
Time Frame: Two years
Lung function testing
Two years
Diary
Time Frame: Two years
Participants will register COPD symptoms, use of reliever medication and exacerbations
Two years
Adverse effects
Time Frame: Two years
Two years
6 minutes walking test - walking distance within 6 minutes (measured in meters)
Time Frame: Two years
Two years
'Medical Research Council Dyspnea Scale' (MRC)
Time Frame: Two years
Acknowledged international scale for measuring the level of dyspnea and physical capability of patients with COPD
Two years
Endogen NO in expiratory breath and Impulse Oscillometry.
Time Frame: Two years
Two years
Blood- and urine samples
Time Frame: Two years
Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Gunnar Kjems APS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 27, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 3, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9727e

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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