Daily Magnesium-supplement for Severe Asthmatics

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 reveal possible beneficial effects of daily magnesium supplement for severe asthmatics, refractory to conventional treatment.

Official Title
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Daily Magnesium-supplement With Mablet for Steroid-resistant, Severe Asthmatics

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Mablet (Magnesium-supplement)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe asthmatics, refractory to conventional treatment, including systemic steroid treatment; symptoms must be annual. Exclusion Criteria: Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, major changes in eating habits within three months prior to study start and during the study period of approximately 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: 18 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: Mablet (Magnesium-supplement)<br>* 3 tablets daily for 12 weeks of Mablet (360 mg magnesium hydroxide/ -oxide) Produced by: Gunnar Kjems APS<br>* Other names: Mablet;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 3 placebo tablets daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control test (ACT) | Questionnaire providing a level of disease control | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D | Questionnaire providing a degree of quality of life | Two years | 
| Spirometry | Lung function testing | Two years | 
| Reversibility testing | Lung function reversibility testing with beta2-agonists | Two years | 
| Diary | Participants will register asthma symptoms, use of reliever medication and exacerbations | Two years | 
| Adverse effects |  | 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 | 
| Endogen NO in expiratory breath and Impulse Oscillometry. |  | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Steroid-resistant, Severe asthmatics, Annual symptoms, Daily magnesium supplement, ACT (asthma control test)