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NCT Number: NCT01113151

Daily Magnesium-supplement for Severe Asthmatics

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Dept. of Respiratory Medicine, Aarhus University Hospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mablet (Magnesium-supplement)

Dietary Supplement

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

Other names: Mablet

Placebo

Other

3 placebo tablets daily for 12 weeks

Primary outcomes

  1. Asthma control test (ACT)

    Time frame: Two years

    Questionnaire providing a level of disease control

Secondary outcomes

  1. EQ-5D

    Time frame: Two years

    Questionnaire providing a degree of quality of life

  2. Spirometry

    Time frame: Two years

    Lung function testing

  3. Reversibility testing

    Time frame: Two years

    Lung function reversibility testing with beta2-agonists

  4. Diary

    Time frame: Two years

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

  5. Adverse effects

    Time frame: Two years

  6. Blood- and urine samples

    Time frame: Two years

    Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine

  7. Endogen NO in expiratory breath and Impulse Oscillometry.

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark
  • Gunnar Kjems APS

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2010
Registry last updated
Sep 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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