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Completed

NCT Number: NCT01118936

Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease

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 study the effect of a daily magnesium supplement for COPD-patients

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 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

  • COPD-patients, grade moderate-severe (FEV1 30-80 % of expected. FEV1/FVC < 0,7).

Exclusion criteria

  • Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, submission to hospital within the last two years, submission to hospital with exacerbation during the study period, major changes in eating habits within three months prior to study start and during the study period of approx.one year various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.

Treatment and study plan

Magnesium supplement (magnesium hydroxide/ -oxide)

Dietary Supplement

3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS

Other names: Mablet

Placebo

Dietary Supplement

3 tablets of placebo daily for 12 weeks

Primary outcomes

  1. EQ-5D

    Time frame: Two years

    Questionnaire providing a degree of quality of life

Secondary outcomes

  1. Spirometry

    Time frame: Two years

    Lung function testing

  2. Diary

    Time frame: Two years

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

  3. Adverse effects

    Time frame: Two years

  4. 6 minutes walking test - walking distance within 6 minutes (measured in meters)

    Time frame: Two years

  5. 'Medical Research Council Dyspnea Scale' (MRC)

    Time frame: Two years

    Acknowledged international scale for measuring the level of dyspnea and physical capability of patients with COPD

  6. Endogen NO in expiratory breath and Impulse Oscillometry.

    Time frame: Two years

  7. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Gunnar Kjems APS

Registry information

Official study title

Daily Mablet-treatment of Patients With COPD

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 7, 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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