Clinical trial NCT01118936: Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease
Official title: Daily Mablet-treatment of Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Chronic Obstructive Pulmonary Disease
Daily magnesium supplement
EQ-5D
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Gunnar Kjems APS
name: Aarhus University Hospital
First posted: 2010-05-07
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: EQ-5D
timeFrame: Two years
Secondary outcomes:
measure: Spirometry
timeFrame: Two years
measure: Diary
timeFrame: Two years
measure: Adverse effects
timeFrame: Two years
measure: 6 minutes walking test - walking distance within 6 minutes (measured in meters)
timeFrame: Two years
measure: 'Medical Research Council Dyspnea Scale' (MRC)
timeFrame: Two years
measure: Endogen NO in expiratory breath and Impulse Oscillometry.
timeFrame: Two years
measure: Blood- and urine samples
timeFrame: Two years
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Research Dept. of Respiratory Medicine, Aarhus University Hospital
Study officials:
affiliation: Dept. of Respiratory Medicine, Aarhus University Hospital, Aarhus, Denmark
name: Ronald Dahl, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
citation: Abreu Gonzalez J, Hernandez Garcia C, Abreu Gonzalez P, Martin Garcia C, Jimenez A. [Effect of intravenous magnesium sulfate on chronic obstructive pulmonary disease exacerbations requiring hospitalization: a randomized placebo-controlled trial]. Arch Bronconeumol. 2006 Aug;42(8):384-7. doi: 10.1016/s1579-2129(06)60551-x. Spanish.