Daily Magnesium-supplement for Severe Asthmatics

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Dietary Supplement: Mablet (Magnesium-supplement); Other: Placebo

• Registration Number: NCT01113151
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Study Start: 2011-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-03
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mablet	Mablet (Magnesium-supplement)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Asthma control test (ACT)	Two years	Questionnaire providing a level of disease control

Secondary Outcome Measures

Name	Time	Method
EQ-5D	Two years	Questionnaire providing a degree of quality of life
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
Adverse effects	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
Endogen NO in expiratory breath and Impulse Oscillometry.	Two years

Trial Locations

Locations (1)

Research Dept. of Respiratory Medicine, Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark