Clinical trial NCT01113151: Daily Magnesium-supplement for Severe Asthmatics
Official title: Daily Magnesium-supplement With Mablet for Steroid-resistant, Severe Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Steroid-resistant
Severe asthmatics
Annual symptoms
Daily magnesium supplement
ACT (asthma control test)
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Gunnar Kjems APS
name: GCP-unit at Aarhus University Hospital, Aarhus, Denmark
name: Aarhus University Hospital
First posted: 2010-04-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Asthma control test (ACT)
timeFrame: Two years
Secondary outcomes:
measure: EQ-5D
timeFrame: Two years
measure: Spirometry
timeFrame: Two years
measure: Reversibility testing
timeFrame: Two years
measure: Diary
timeFrame: Two years
measure: Adverse effects
timeFrame: Two years
measure: Blood- and urine samples
timeFrame: Two years
measure: Endogen NO in expiratory breath and Impulse Oscillometry.
timeFrame: Two years
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Research Dept. of Respiratory Medicine, Aarhus University Hospital
Study officials:
affiliation: Dept. of Respiratory Medicine, Aarhus University Hospital, Denmark
name: Ronald Dahl, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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