COPD
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Daily magnesium supplement, EQ-5D
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
Interventions
DIETARY_SUPPLEMENTMagnesium supplement (magnesium hydroxide/ -oxide)
3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
DIETARY_SUPPLEMENTPlacebo
3 tablets of placebo daily for 12 weeks
Sponsors
Gunnar Kjems APS
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D | Two years | Questionnaire providing a degree of quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diary | Two years | Participants will register COPD symptoms, use of reliever medication and exacerbations |
| Adverse effects | Two years | — |
| 6 minutes walking test - walking distance within 6 minutes (measured in meters) | Two years | — |
| Spirometry | Two years | Lung function testing |
| Endogen NO in expiratory breath and Impulse Oscillometry. | Two years | — |
| Blood- and urine samples | Two years | Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine |
| 'Medical Research Council Dyspnea Scale' (MRC) | Two years | Acknowledged international scale for measuring the level of dyspnea and physical capability of patients with COPD |
Countries
Denmark
Outcome results
None listed