Daily Magnesium-supplement for Severe Asthmatics

This study is currently recruiting participants.

Verified June 2012 by University of Aarhus

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: June 18, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 27, 2010

Last Updated Date

June 18, 2012

Start Date ^ICMJE

April 2011

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Asthma control test (ACT) [ Time Frame: Two years ] [ Designated as safety issue: No ]

Questionnaire providing a level of disease control

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01113151 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Daily Magnesium-supplement for Severe Asthmatics

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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

Study Arm (s)

No Intervention: Washout
Active Comparator: Mablet
Intervention: Dietary Supplement: Mablet (Magnesium-supplement)
Placebo Comparator: Placebo
Intervention: Other: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ronald Dahl, Professor	+4589492106	ronadahl@rm.dk
Contact: Mette KB Dolberg, Cand. med.	+4589492106	mettdolb@rm.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01113151

Other Study ID Numbers ^ICMJE

9727c

Has Data Monitoring Committee

Yes

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital

Investigators ^ICMJE

Principal Investigator:

Ronald Dahl, Professor

Dept. of Respiratory Medicine, Aarhus University Hospital, Denmark

Information Provided By

University of Aarhus

Verification Date

June 2012

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

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