Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

• Conditions: COPD
• Interventions: Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide); Dietary Supplement: Placebo

• Registration Number: NCT01118936
• Lead Sponsor: University of Aarhus

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Study Start: 2010-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-03
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mablet	Magnesium supplement (magnesium hydroxide/ -oxide)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
EQ-5D	Two years	Questionnaire providing a degree of quality of life

Secondary Outcome Measures

Name	Time	Method
Spirometry	Two years	Lung function testing
Diary	Two years	Participants will register COPD symptoms, use of reliever medication and exacerbations
Adverse effects	Two years
6 minutes walking test - walking distance within 6 minutes (measured in meters)	Two years
'Medical Research Council Dyspnea Scale' (MRC)	Two years	Acknowledged international scale for measuring the level of dyspnea and physical capability of patients with COPD
Endogen NO in expiratory breath and Impulse Oscillometry.	Two years
Blood- and urine samples	Two years	Se-magnesium, dU-magnesium, se-creatinin, se-potassium, se-sodium, se-albumine, se-Ca2+, se-phosphate, dU-Ca and dU-creatinine

Trial Locations

Locations (1)

Research Dept. of Respiratory Medicine, Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark