- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01564953
Magnesium is Associated With QoL in COPD: A Cross-sectional Study
Serum Magnesium and Nit Vitamin D is Associated With Better QoL in COPD: A Cross-sectional Study
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aarhus, Denmark, 8000
- Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Vitamin D
Time Frame: one year
|
vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung Function Test
Time Frame: one year
|
Forced expiratory ventilation in 1 second, in percent of predicted
|
one year
|
Serum Magnesium
Time Frame: One year
|
Serum magnesium in plasma, in mmol/L
|
One year
|
Serum Calcium
Time Frame: One year
|
Serum ionized calcium, in mmol/L
|
One year
|
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).
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ronald Dahl, Professor, Allergy Centre, Odense University Hospital
- Principal Investigator: Sarah HA Hussein, MD, Department of Respiratory Diseases, Aarhus University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-20110280
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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