Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease
Overview
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
Full Title of Study: “Daily Mablet-treatment of Patients With COPD”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: March 2013
Interventions
- Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide)
- 3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
- Dietary Supplement: Placebo
- 3 tablets of placebo daily for 12 weeks
Arms, Groups and Cohorts
- No Intervention: Washout
- Active Comparator: Mablet
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary Measures
- EQ-5D
- Time Frame: Two years
- Questionnaire providing a degree of quality of life
Secondary Measures
- Spirometry
- Time Frame: Two years
- Lung function testing
- Diary
- Time Frame: Two years
- Participants will register COPD symptoms, use of reliever medication and exacerbations
- Adverse effects
- Time Frame: Two years
- 6 minutes walking test – walking distance within 6 minutes (measured in meters)
- Time Frame: 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
- Endogen NO in expiratory breath and Impulse Oscillometry.
- Time Frame: 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
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University of Aarhus
- Collaborator
- Gunnar Kjems APS
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Ronald Dahl, Professor, Principal Investigator, Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark
References
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Fogarty A, Lewis SA, Scrivener SL, Antoniak M, Pacey S, Pringle M, Britton J. Oral magnesium and vitamin C supplements in asthma: a parallel group randomized placebo-controlled trial. Clin Exp Allergy. 2003 Oct;33(10):1355-9. doi: 10.1046/j.1365-2222.2003.01777.x.
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Abreu Gonzalez J, Hernandez Garcia C, Abreu Gonzalez P, Martin Garcia C, Jimenez A. [Effect of intravenous magnesium sulfate on chronic obstructive pulmonary disease exacerbations requiring hospitalization: a randomized placebo-controlled trial]. Arch Bronconeumol. 2006 Aug;42(8):384-7. doi: 10.1016/s1579-2129(06)60551-x. Erratum In: Arch Bronconeumol. 2006 Oct;42(10):491. Spanish.
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