Daily Magnesium-supplement for Severe Asthmatics

University of Aarhus5 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

Mablet (Magnesium-supplement)DIETARY_SUPPLEMENT

3 tablets daily for 12 weeks of Mablet (360 mg magnesium hydroxide/ -oxide) Produced by: Gunnar Kjems APS

PlaceboOTHER

3 placebo tablets daily for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Research Dept. of Respiratory Medicine, Aarhus University Hospital

Aarhus C, Denmark

Outcomes

Primary Outcomes

Asthma control test (ACT)

Questionnaire providing a level of disease control

Time frame: Two years

Secondary Outcomes

EQ-5D

Questionnaire providing a degree of quality of life

Time frame: Two years

Spirometry

Lung function testing

Time frame: Two years

Reversibility testing

Lung function reversibility testing with beta2-agonists

Time frame: Two years

Diary

Participants will register asthma symptoms, use of reliever medication and exacerbations

Time frame: Two years

Adverse effects

Time frame: 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

Time frame: Two years

Endogen NO in expiratory breath and Impulse Oscillometry.

Time frame: Two years

Data from ClinicalTrials.gov

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