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Completed

NCT Number: NCT01564953

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

  1. Serum Vitamin D

    Time frame: one year

    vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L

Secondary outcomes

  1. Lung Function Test

    Time frame: one year

    Forced expiratory ventilation in 1 second, in percent of predicted

  2. Serum Magnesium

    Time frame: One year

    Serum magnesium in plasma, in mmol/L

  3. Serum Calcium

    Time frame: One year

    Serum ionized calcium, in mmol/L

  4. Quality of Life

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

Serum Magnesium and Nit Vitamin D is Associated With Better QoL in COPD: A Cross-sectional Study

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 28, 2012
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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