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Daily Magnesium-supplement for Severe Asthmatics

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ClinicalTrials.gov Identifier: NCT01113151
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : September 4, 2013
Sponsor:
Collaborators:
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Asthma Dietary Supplement: Mablet (Magnesium-supplement) Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daily Magnesium-supplement With Mablet for Steroid-resistant, Severe Asthmatics
Study Start Date : April 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arm Intervention/treatment
No Intervention: Washout
Active Comparator: Mablet Dietary Supplement: Mablet (Magnesium-supplement)
3 tablets daily for 12 weeks of Mablet (360 mg magnesium hydroxide/ -oxide) Produced by: Gunnar Kjems APS
Other Name: Mablet

Placebo Comparator: Placebo Other: Placebo
3 placebo tablets daily for 12 weeks




Primary Outcome Measures :
  1. Asthma control test (ACT) [ Time Frame: Two years ]
    Questionnaire providing a level of disease control


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113151


Locations
Denmark
Research Dept. of Respiratory Medicine, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital
Investigators
Principal Investigator: Ronald Dahl, Professor Dept. of Respiratory Medicine, Aarhus University Hospital, Denmark

Publications:

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01113151     History of Changes
Other Study ID Numbers: 9727c
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013

Keywords provided by University of Aarhus:
Steroid-resistant
Severe asthmatics
Annual symptoms
Daily magnesium supplement
ACT (asthma control test)

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases