Daily Magnesium-supplement for Severe Asthmatics

This study has been completed.
Sponsor:
Collaborators:
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01113151
First received: April 27, 2010
Last updated: September 3, 2013
Last verified: September 2013

April 27, 2010
September 3, 2013
April 2011
March 2013   (final data collection date for primary outcome measure)
Asthma control test (ACT) [ Time Frame: Two years ] [ Designated as safety issue: No ]
Questionnaire providing a level of disease control
Same as current
Complete list of historical versions of study NCT01113151 on ClinicalTrials.gov Archive Site
  • EQ-5D [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Questionnaire providing a degree of quality of life
  • Spirometry [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Lung function testing
  • Reversibility testing [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Lung function reversibility testing with beta2-agonists
  • Diary [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Participants will register asthma symptoms, use of reliever medication and exacerbations
  • Adverse effects [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
  • Blood- and urine samples [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Daily Magnesium-supplement for Severe Asthmatics
Daily Magnesium-supplement With Mablet for Steroid-resistant, 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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
  • Other: Placebo
    3 placebo tablets daily for 12 weeks
    Other Name: Placebo
  • No Intervention: Washout
  • Active Comparator: Mablet
    Intervention: Dietary Supplement: Mablet (Magnesium-supplement)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01113151
9727c
Yes
University of Aarhus
University of Aarhus
  • Gunnar Kjems APS
  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark
  • Aarhus University Hospital
Principal Investigator: Ronald Dahl, Professor Dept. of Respiratory Medicine, Aarhus University Hospital, Denmark
University of Aarhus
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP