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Clinical Trials/NCT01113151
NCT01113151CompletedNot Applicable

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

University of Aarhus2 sites in 1 country5 target enrollmentStarted: April 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
5
Locations
2
Primary Endpoint
Asthma control test (ACT)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Asthma control test (ACT)

Time Frame: Two years

Questionnaire providing a level of disease control

Secondary Outcomes

  • EQ-5D(Two years)
  • Spirometry(Two years)
  • Reversibility testing(Two years)
  • Diary(Two years)
  • Adverse effects(Two years)
  • Blood- and urine samples(Two years)
  • Endogen NO in expiratory breath and Impulse Oscillometry.(Two years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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