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Daily Magnesium-supplement for Severe Asthmatics

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mablet (Magnesium-supplement)
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Steroid-resistant, Severe asthmatics, Annual symptoms, Daily magnesium supplement, ACT (asthma control test)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Dept. of Respiratory Medicine, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Placebo Comparator

Arm Label

Washout

Mablet

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Asthma control test (ACT)
Questionnaire providing a level of disease control

Secondary Outcome Measures

EQ-5D
Questionnaire providing a degree of quality of life
Spirometry
Lung function testing
Reversibility testing
Lung function reversibility testing with beta2-agonists
Diary
Participants will register asthma symptoms, use of reliever medication and exacerbations
Adverse effects
Blood- and urine samples
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.

Full Information

First Posted
April 27, 2010
Last Updated
September 3, 2013
Sponsor
University of Aarhus
Collaborators
Gunnar Kjems APS, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01113151
Brief Title
Daily Magnesium-supplement for Severe Asthmatics
Official Title
Daily Magnesium-supplement With Mablet for Steroid-resistant, Severe Asthmatics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Gunnar Kjems APS, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Steroid-resistant, Severe asthmatics, Annual symptoms, Daily magnesium supplement, ACT (asthma control test)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Washout
Arm Type
No Intervention
Arm Title
Mablet
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Mablet (Magnesium-supplement)
Other Intervention Name(s)
Mablet
Intervention Description
3 tablets daily for 12 weeks of Mablet (360 mg magnesium hydroxide/ -oxide) Produced by: Gunnar Kjems APS
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
3 placebo tablets daily for 12 weeks
Primary Outcome Measure Information:
Title
Asthma control test (ACT)
Description
Questionnaire providing a level of disease control
Time Frame
Two years
Secondary Outcome Measure Information:
Title
EQ-5D
Description
Questionnaire providing a degree of quality of life
Time Frame
Two years
Title
Spirometry
Description
Lung function testing
Time Frame
Two years
Title
Reversibility testing
Description
Lung function reversibility testing with beta2-agonists
Time Frame
Two years
Title
Diary
Description
Participants will register asthma symptoms, use of reliever medication and exacerbations
Time Frame
Two years
Title
Adverse effects
Time Frame
Two years
Title
Blood- and urine samples
Description
Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine
Time Frame
Two years
Title
Endogen NO in expiratory breath and Impulse Oscillometry.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Dahl, Professor
Organizational Affiliation
Dept. of Respiratory Medicine, Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Dept. of Respiratory Medicine, Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
14634861
Citation
Schlingmann KP, Konrad M, Seyberth HW. Genetics of hereditary disorders of magnesium homeostasis. Pediatr Nephrol. 2004 Jan;19(1):13-25. doi: 10.1007/s00467-003-1293-z. Epub 2003 Nov 22.
Results Reference
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PubMed Identifier
17218820
Citation
Beasley R, Aldington S. Magnesium in the treatment of asthma. Curr Opin Allergy Clin Immunol. 2007 Feb;7(1):107-10. doi: 10.1097/ACI.0b013e328012ce4b.
Results Reference
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PubMed Identifier
10836320
Citation
Emelyanov A, Fedoseev G, Barnes PJ. Reduced intracellular magnesium concentrations in asthmatic patients. Eur Respir J. 1999 Jan;13(1):38-40. doi: 10.1183/09031936.99.13103899.
Results Reference
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PubMed Identifier
9680494
Citation
Dominguez LJ, Barbagallo M, Di Lorenzo G, Drago A, Scola S, Morici G, Caruso C. Bronchial reactivity and intracellular magnesium: a possible mechanism for the bronchodilating effects of magnesium in asthma. Clin Sci (Lond). 1998 Aug;95(2):137-42.
Results Reference
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PubMed Identifier
11028655
Citation
Alamoudi OS. Hypomagnesaemia in chronic, stable asthmatics: prevalence, correlation with severity and hospitalization. Eur Respir J. 2000 Sep;16(3):427-31. doi: 10.1034/j.1399-3003.2000.016003427.x.
Results Reference
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PubMed Identifier
14979636
Citation
Bede O, Suranyi A, Pinter K, Szlavik M, Gyurkovits K. Urinary magnesium excretion in asthmatic children receiving magnesium supplementation: a randomized, placebo-controlled, double-blind study. Magnes Res. 2003 Dec;16(4):262-70.
Results Reference
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PubMed Identifier
16254259
Citation
Aziz HS, Blamoun AI, Shubair MK, Ismail MM, DeBari VA, Khan MA. Serum magnesium levels and acute exacerbation of chronic obstructive pulmonary disease: a retrospective study. Ann Clin Lab Sci. 2005 Autumn;35(4):423-7.
Results Reference
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PubMed Identifier
18043278
Citation
Rowe BH, Camargo CA Jr. The role of magnesium sulfate in the acute and chronic management of asthma. Curr Opin Pulm Med. 2008 Jan;14(1):70-6. doi: 10.1097/MCP.0b013e3282f19867.
Results Reference
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PubMed Identifier
15726901
Citation
Nasulewicz A, Zimowska W, Bayle D, Dzimira S, Madej J, Rayssiguier Y, Opolski A, Mazur A. Changes in gene expression in the lungs of Mg-deficient mice are related to an inflammatory process. Magnes Res. 2004 Dec;17(4):259-63.
Results Reference
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PubMed Identifier
16788707
Citation
Gontijo-Amaral C, Ribeiro MA, Gontijo LS, Condino-Neto A, Ribeiro JD. Oral magnesium supplementation in asthmatic children: a double-blind randomized placebo-controlled trial. Eur J Clin Nutr. 2007 Jan;61(1):54-60. doi: 10.1038/sj.ejcn.1602475. Epub 2006 Jun 21.
Results Reference
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PubMed Identifier
14519140
Citation
Fogarty A, Lewis SA, Scrivener SL, Antoniak M, Pacey S, Pringle M, Britton J. Oral magnesium and vitamin C supplements in asthma: a parallel group randomized placebo-controlled trial. Clin Exp Allergy. 2003 Oct;33(10):1355-9. doi: 10.1046/j.1365-2222.2003.01777.x.
Results Reference
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PubMed Identifier
9387944
Citation
Hill J, Micklewright A, Lewis S, Britton J. Investigation of the effect of short-term change in dietary magnesium intake in asthma. Eur Respir J. 1997 Oct;10(10):2225-9. doi: 10.1183/09031936.97.10102225.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Daily Magnesium-supplement for Severe Asthmatics

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