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Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT01118936
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : September 4, 2013
Sponsor:
Collaborators:
Gunnar Kjems APS
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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 or disease Intervention/treatment Phase
COPD Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide) Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daily Mablet-treatment of Patients With COPD
Study Start Date : October 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. EQ-5D [ Time Frame: Two years ]
    Questionnaire providing a degree of quality of life


Secondary Outcome Measures :
  1. Spirometry [ Time Frame: Two years ]
    Lung function testing

  2. Diary [ Time Frame: Two years ]
    Participants will register COPD symptoms, use of reliever medication and exacerbations

  3. Adverse effects [ Time Frame: Two years ]
  4. 6 minutes walking test - walking distance within 6 minutes (measured in meters) [ Time Frame: Two years ]
  5. '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

  6. Endogen NO in expiratory breath and Impulse Oscillometry. [ Time Frame: Two years ]
  7. 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



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01118936     History of Changes
Other Study ID Numbers: 9727e
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013

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

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