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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01564953
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Aarhus University Hospital
Information provided by (Responsible Party):
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.

Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)

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.

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Study Type : Observational
Actual Enrollment : 143 participants
Time Perspective: Cross-Sectional
Official Title: Serum Magnesium and Nit Vitamin D is Associated With Better QoL in COPD: A Cross-sectional Study
Study Start Date : February 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Magnesium

Primary Outcome Measures :
  1. Serum Vitamin D [ Time Frame: one year ]
    vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L

Secondary Outcome Measures :
  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).

Biospecimen Retention:   Samples Without DNA

Blood samples:

p-creatinine p-potassium p-sodium p-albumine p-phosphate p-magnesium p-calcium-ion p-parathyrine p-25-hydroxy-vitamin D2 + D3

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients from the Department Of Resoiratory Diseases, Aarhus University Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01564953

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Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
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Study Director: Ronald Dahl, Professor Allergy Centre, Odense University Hospital
Principal Investigator: Sarah HA Hussein, MD Department of Respiratory Diseases, Aarhus University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Aarhus Identifier: NCT01564953    
Other Study ID Numbers: M-20110280
First Posted: March 28, 2012    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017
Last Verified: January 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publish as paper in Scientific journal
Keywords provided by University of Aarhus:
vitamin D
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases