Clinical trial NCT01564953: Magnesium is Associated With QoL in COPD: A Cross-sectional Study
Official title: Serum Magnesium and Nit Vitamin D is Associated With Better QoL in COPD: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: vitamin D
calcium
magnesium
COPD
QoL
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2012-03-28
Enrollment: 143
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients from the Department Of Resoiratory Diseases, Aarhus University Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Vitamin D
timeFrame: one year
Secondary outcomes:
measure: Lung Function Test
timeFrame: one year
measure: Serum Magnesium
timeFrame: One year
measure: Serum Calcium
timeFrame: One year
measure: Quality of Life
timeFrame: One year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Allergy Centre, Odense University Hospital
name: Ronald Dahl, Professor
role: STUDY_DIRECTOR
affiliation: Department of Respiratory Diseases, Aarhus University Hospital
name: Sarah HA Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.