Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Serum Vitamin D | vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Function Test | Forced expiratory ventilation in 1 second, in percent of predicted | one year |
| Serum Magnesium | Serum magnesium in plasma, in mmol/L |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Outpatients from the Department Of Resoiratory Diseases, Aarhus University Hospital
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronald Dahl, Professor | Allergy Centre, Odense University Hospital | Study Director |
| Sarah HA Hussein, MD | Department of Respiratory Diseases, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25892292 | Derived | 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. |
Not provided
Not provided
Publish as paper in Scientific journal
Not provided
Not provided
Not provided
Not provided
Missed inclusion was due to either unstable disease (54 patients) or unwillingness to participate (87 patients).
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Serum Vitamin D, Magnesium and Calcium Deficient Groups | Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Serum Vitamin D, Magnesium and Calcium Deficient Groups | Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Vitamin D | vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L | Posted | Mean | Standard Deviation | mmol/L | one year |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events were not collected for the 143 participants |
Not provided
Not provided
The cross-sectional design. Some data (e.g. number of exacerbations past one year and smoking history) were self-reported and therefore, a risk of recall-bias cannot be excluded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Hashim Ali Hussein | Aarhus University Hospital | 0045 42660308 | sarsuri@hotmail.com |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
| One year |
| Serum Calcium | Serum ionized calcium, in mmol/L | 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). | One year |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Lung Function Test | Forced expiratory ventilation in 1 second, in percent of predicted | Posted | Mean | Full Range | percentage of predicted | one year |
|
|
|
| Secondary | Serum Magnesium | Serum magnesium in plasma, in mmol/L | Posted | Mean | Standard Deviation | mmol/L | One year |
|
|
|
| Secondary | Serum Calcium | Serum ionized calcium, in mmol/L | Posted | Mean | Standard Deviation | mmol/L | One year |
|
|
|
| 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). | Posted | Mean | Full Range | units on a scale | One year |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |