Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
vitamin D, calcium, magnesium, COPD, QoL
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.
Interventions
None listed
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Vitamin D | one year | vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Function Test | one year | Forced expiratory ventilation in 1 second, in percent of predicted |
| Serum Magnesium | One year | Serum magnesium in plasma, in mmol/L |
| Serum Calcium | One year | Serum ionized calcium, in mmol/L |
| Quality of Life | 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). |
Countries
Denmark
Participant flow
Recruitment details
Recruitment took place in an outpatient clinic for respiratory diseases in Aarhus University Hospital, Denmark, during summertime in order to minimize seasonal variations of serum vitamin D.
Pre-assignment details
Missed inclusion was due to either unstable disease (54 patients) or unwillingness to participate (87 patients).
Participants by arm
| Arm | Count |
|---|---|
| Serum Vitamin D, Magnesium and Calcium Deficient Groups Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency. | 143 |
| Total | 143 |
Baseline characteristics
| Characteristic | Serum Vitamin D, Magnesium and Calcium Deficient Groups |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 99 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Age, Continuous | 70 years |
| Gender Female | 66 Participants |
| Gender Male | 77 Participants |
| Region of Enrollment Denmark | 143 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Serum Vitamin D
vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serum Vitamin D | Serum Vitamin D | 75.13 mmol/L | Standard Deviation 33.62 |
Secondary
Lung Function Test
Forced expiratory ventilation in 1 second, in percent of predicted
Time frame: one year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Serum Vitamin D | Lung Function Test | 52 percentage of predicted |
Secondary
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).
Time frame: One year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Serum Vitamin D | Quality of Life | 24 units on a scale |
Secondary
Serum Calcium
Serum ionized calcium, in mmol/L
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serum Vitamin D | Serum Calcium | 1.23 mmol/L | Standard Deviation 0.04 |
Secondary
Serum Magnesium
Serum magnesium in plasma, in mmol/L
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serum Vitamin D | Serum Magnesium | 0.82 mmol/L | Standard Deviation 0.08 |