Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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

Official Title
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Daily Mablet-treatment of Patients With COPD

Conditions
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COPD

Intervention / Treatment
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* Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry | Lung function testing | Two years | 
| Diary | Participants will register COPD symptoms, use of reliever medication and exacerbations | Two years | 
| Adverse effects |  | Two years | 
| 6 minutes walking test - walking distance within 6 minutes (measured in meters) |  | Two years | 
| 'Medical Research Council Dyspnea Scale' (MRC) | 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. |  | Two years | 
| Blood- and urine samples | Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Daily magnesium supplement, EQ-5D