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
  Purpose

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 Intervention
Asthma
Dietary Supplement: Mablet (Magnesium-supplement)
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daily Magnesium-supplement With Mablet for Steroid-resistant, Severe Asthmatics

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Asthma control test (ACT) [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Questionnaire providing a level of disease control


Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01113151     History of Changes
Other Study ID Numbers: 9727c
Study First Received: April 27, 2010
Last Updated: September 3, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on October 23, 2014