Magnesium is Associated With QoL in COPD: A Cross-sectional Study

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT01564953
• Lead Sponsor: University of Aarhus

Brief Summary

The aim of this study was to investigate the associations between serum concentrations of vitamin D, Magnesium and Calcium in Chronic obstructive pulmonary disease patients and the potential impact of these parameters on lung function and quality of life.

Detailed Description

Attention is enhancing worldwide on the increasing tendency of insufficient 25-hydroxyvitamin D serum levels. New insights into the role of vitamin D and distribution of its receptors in the human body have been revealed. Presumably, this entails implications concerning disease and treatment that go far beyond the well-known field of bone-metabolism.

Vitamin D deficiency is common in patients with chronic obstructive pulmonary disease (COPD), and reductions in vitamin D serum levels have formerly been perceived as a consequence rather than a cause of COPD.

Yet, there is a lack of consensus concerning the role of vitamin D on the decreasing lung function in COPD.

Some trials have revealed a high degree of co-variation between the grade of airway obstruction, intake of vitamin D and reduction of serum-vitamin D. Other claim that vitamin D appears to be capable of inhibiting pulmonary inflammatory responses.

Vitamin D interacts with calcium and magnesium and this subtle balance might be highly relevant in the progression of inflammatory diseases like COPD. Presumably, Mg inhibits contraction and relaxes smooth muscles in airways due to blocking of calcium-ion-flux across the cell membrane.

The aim of this study is to investigate the status of vitamin D, magnesium and calcium in COPD, and to study the relationship and impact of vitamin D, magnesium and calcium in COPD-patients.

The hypothesis of this study is that COPD-patients with vitamin D-, magnesium- and calcium supplement have a better lung function and quality of life, than those who have vitamin D-, magnesium- and calcium deficiency.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Primary Completion: 2012-10
• Status Verified: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2015-05-31
• Results First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Results First Posted: 2017-03-06
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• COPD-patients
• Unchanged medical treatment for COPD for the last 4 weeks
• Outpatients
• adults over 40 years

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Exclusion Criteria

• COPD exacerbation, which resulted in hospitalization and/or modification of medical treatment within 4 weeks
• Patients with other lung diseases, such as active tuberculosis, lung cancer, sarcoidosis and pulmonary fibrosis
• diseases affecting vitamin D and/or calcium and/or magnesium distribution
• Previous lung resection
• Treatment with systemic steroids
• Known addiction problems with alcohol and/or drugs

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum Vitamin D	one year	vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L

Secondary Outcome Measures

Name	Time	Method
Lung Function Test	one year	Forced expiratory ventilation in 1 second, in percent of predicted
Serum Magnesium	One year	Serum magnesium in plasma, in mmol/L
Serum Calcium	One year	Serum ionized calcium, in mmol/L
Quality of Life	One year	Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test. Minimum score was 0 (no symptoms) and maximum score was 40 (many symptoms).

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark