Chronic Obstructive Pulmonary Disease (COPD)NCT01564953
Magnesium is Associated With QoL in COPD: A Cross-sectional Study
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 143 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients from the Department Of Resoiratory Diseases, Aarhus University Hospital
Who may be able to join
- COPD-patients
- Unchanged medical treatment for COPD for the last 4 weeks
- Outpatients
- adults over 40 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Magnesium and Nit Vitamin D is Associated With Better 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.
Read the 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.
- Keywords
- vitamin D, calcium, magnesium, COPD, QoL
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Vitamin D
vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L
Measured: one year
Secondary outcomes (4)
Lung Function Test
Forced expiratory ventilation in 1 second, in percent of predicted
Measured: one year
Serum Magnesium
Serum magnesium in plasma, in mmol/L
Measured: One year
Serum Calcium
Serum ionized calcium, in mmol/L
Measured: One year
Quality of Life
Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test. Minimum score was 0 (no symptoms) and maximum score was 40 (many symptoms).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Ronald Dahl, Professor, Study director, Allergy Centre, Odense University HospitalSarah HA Hussein, MD, Principal investigator, Department of Respiratory Diseases, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564953
- Sponsor's protocol ID
- M-20110280
- Status last verified
- Jan 2013
- First submitted
- 26 Mar 2012
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publish as paper in Scientific journal
Publications
Hashim Ali Hussein S, Nielsen LP, Konow Bogebjerg Dolberg M, Dahl R. Serum magnesium and not vitamin D is associated with better QoL in COPD: A cross-sectional study. Respir Med. 2015 Jun;109(6):727-33. doi: 10.1016/j.rmed.2015.03.005. Epub 2015 Mar 27.
PubMed 25892292
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Magnesium and Nit Vitamin D is Associated With Better QoL in COPD: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT01564953
- Acronym / sponsor ID
- M-20110280
- Keywords
- vitamin D, calcium, magnesium, COPD, QoL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Mar 2012 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients from the Department Of Resoiratory Diseases, Aarhus University Hospital
Key inclusion criteria (4 listed)
- COPD-patients
- Unchanged medical treatment for COPD for the last 4 weeks
- Outpatients
- adults over 40 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Vitamin D
Time frame: one year
vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L
4 secondary outcomes
Lung Function Test
Time frame: one year
Serum Magnesium
Time frame: One year
Serum Calcium
Time frame: One year
Quality of Life
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25892292Hashim Ali Hussein S, Nielsen LP, Konow Bogebjerg Dolberg M, Dahl R. Serum magnesium and not vitamin D is associated with better QoL in COPD: A cross-sectional study. Respir Med. 2015 Jun;109(6):727-33. doi: 10.1016/j.rmed.2015.03.005. Epub 2015 Mar 27.
- Individual participant dataSharing planned: Yes. Publish as paper in Scientific journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Dahl, Professor study director
Allergy Centre, Odense University Hospital
Sarah HA Hussein, MD principal investigator
Department of Respiratory Diseases, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Vitamin D (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01564953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.