Asthma
Conditions
Keywords
Steroid-resistant, Severe asthmatics, Annual symptoms, Daily magnesium supplement, ACT (asthma control test)
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 reveal possible beneficial effects of daily magnesium supplement for severe asthmatics, refractory to conventional treatment.
Interventions
DIETARY_SUPPLEMENTMablet (Magnesium-supplement)
3 tablets daily for 12 weeks of Mablet (360 mg magnesium hydroxide/ -oxide) Produced by: Gunnar Kjems APS
OTHERPlacebo
3 placebo tablets daily for 12 weeks
Sponsors
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
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
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma control test (ACT) | Two years | Questionnaire providing a level of disease control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spirometry | Two years | Lung function testing |
| Reversibility testing | Two years | Lung function reversibility testing with beta2-agonists |
| Diary | Two years | Participants will register asthma symptoms, use of reliever medication and exacerbations |
| EQ-5D | Two years | Questionnaire providing a degree of quality of life |
| 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 |
| Endogen NO in expiratory breath and Impulse Oscillometry. | Two years | — |
| Adverse effects | Two years | — |
Countries
Denmark
Outcome results
None listed