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Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

COPD

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

About this trial

This is an interventional treatment trial for COPD focused on measuring Chronic Obstructive Pulmonary Disease, Daily magnesium supplement, EQ-5D

Eligibility Criteria

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

Inclusion Criteria:

  • COPD-patients, grade moderate-severe (FEV1 30-80 % of expected. FEV1/FVC < 0,7).

Exclusion Criteria:

  • Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, submission to hospital within the last two years, submission to hospital with exacerbation during the study period, major changes in eating habits within three months prior to study start and during the study period of approx.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

EQ-5D
Questionnaire providing a degree of quality of life

Secondary Outcome Measures

Spirometry
Lung function testing
Diary
Participants will register COPD symptoms, use of reliever medication and exacerbations
Adverse effects
6 minutes walking test - walking distance within 6 minutes (measured in meters)
'Medical Research Council Dyspnea Scale' (MRC)
Acknowledged international scale for measuring the level of dyspnea and physical capability of patients with COPD
Endogen NO in expiratory breath and Impulse Oscillometry.
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

Full Information

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

Unique Protocol Identification Number
NCT01118936
Brief Title
Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease
Official Title
Daily Mablet-treatment of Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (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, 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 study the effect of a daily magnesium supplement for COPD-patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Chronic Obstructive Pulmonary Disease, Daily magnesium supplement, EQ-5D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (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)
Magnesium supplement (magnesium hydroxide/ -oxide)
Other Intervention Name(s)
Mablet
Intervention Description
3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
3 tablets of placebo daily for 12 weeks
Primary Outcome Measure Information:
Title
EQ-5D
Description
Questionnaire providing a degree of quality of life
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Spirometry
Description
Lung function testing
Time Frame
Two years
Title
Diary
Description
Participants will register COPD symptoms, use of reliever medication and exacerbations
Time Frame
Two years
Title
Adverse effects
Time Frame
Two years
Title
6 minutes walking test - walking distance within 6 minutes (measured in meters)
Time Frame
Two years
Title
'Medical Research Council Dyspnea Scale' (MRC)
Description
Acknowledged international scale for measuring the level of dyspnea and physical capability of patients with COPD
Time Frame
Two years
Title
Endogen NO in expiratory breath and Impulse Oscillometry.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD-patients, grade moderate-severe (FEV1 30-80 % of expected. FEV1/FVC < 0,7). Exclusion Criteria: Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, submission to hospital within the last two years, submission to hospital with exacerbation during the study period, major changes in eating habits within three months prior to study start and during the study period of approx.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, Aarhus, 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
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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
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Citation
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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-treatment of Patients With Chronic Obstructive Pulmonary Disease

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