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Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Gunnar Kjems APS
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01118936
First received: April 27, 2010
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
COPD
 Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daily Mablet-treatment of Patients With COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • EQ-5D [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Questionnaire providing a degree of quality of life


Secondary Outcome Measures:
  • Spirometry [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Lung function testing

  • Diary [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Participants will register COPD symptoms, use of reliever medication and exacerbations

  • Adverse effects [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • 6 minutes walking test - walking distance within 6 minutes (measured in meters) [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • 'Medical Research Council Dyspnea Scale' (MRC) [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Acknowledged international scale for measuring the level of dyspnea and physical capability of patients with COPD

  • Endogen NO in expiratory breath and Impulse Oscillometry. [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Blood- and urine samples [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine


Estimated Enrollment: 18
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mablet
Placebo Comparator: Placebo Dietary Supplement: Placebo
3 tablets of placebo daily for 12 weeks
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118936

Locations
Denmark
Research Dept. of Respiratory Medicine, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Gunnar Kjems APS
Aarhus University Hospital
Investigators
Principal Investigator: Ronald Dahl, Professor Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark
  More Information

Publications:

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01118936     History of Changes
Other Study ID Numbers: 9727e
Study First Received: April 27, 2010
Last Updated: November 1, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Chronic Obstructive Pulmonary Disease
Daily magnesium supplement
EQ-5D

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
 Magnesium Hydroxide
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013