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Trial record 36 of 118 for:    CALCIUM CATION

Magnesium is Associated With QoL in COPD: A Cross-sectional Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564953
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Condition Chronic Obstructive Pulmonary Disease (COPD)
Enrollment 143
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).
Arm/Group Title Serum Vitamin D, Magnesium and Calcium Deficient Groups
Hide Arm/Group Description Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
Period Title: Overall Study
Started 143
Completed 143
Not Completed 0
Arm/Group Title Serum Vitamin D, Magnesium and Calcium Deficient Groups
Hide Arm/Group Description Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
Overall Number of Baseline Participants 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants
<=18 years
0
   0.0%
Between 18 and 65 years
44
  30.8%
>=65 years
99
  69.2%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 143 participants
70
(63 to 74)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants
Female
66
  46.2%
Male
77
  53.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 143 participants
143
1.Primary Outcome
Title Serum Vitamin D
Hide Description vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Serum Vitamin D
Hide Arm/Group Description:
Participants' serum vitamin D
Overall Number of Participants Analyzed 143
Mean (Standard Deviation)
Unit of Measure: mmol/L
75.13  (33.62)
2.Secondary Outcome
Title Lung Function Test
Hide Description Forced expiratory ventilation in 1 second, in percent of predicted
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lung Function
Hide Arm/Group Description:
lung function measured as forced expiratory volumes in 1 second.
Overall Number of Participants Analyzed 143
Mean (Full Range)
Unit of Measure: percentage of predicted
52
(33 to 71)
3.Secondary Outcome
Title Serum Magnesium
Hide Description Serum magnesium in plasma, in mmol/L
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Serum Magnesium
Hide Arm/Group Description:
Serum magnesium in plasma, in mmol/L
Overall Number of Participants Analyzed 143
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.82  (0.08)
4.Secondary Outcome
Title Serum Calcium
Hide Description Serum ionized calcium, in mmol/L
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Serum Calcium
Hide Arm/Group Description:
Serum ionized calcium, in mmol/L
Overall Number of Participants Analyzed 143
Mean (Standard Deviation)
Unit of Measure: mmol/L
1.23  (0.04)
5.Secondary Outcome
Title Quality of Life
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quality of Life
Hide Arm/Group Description:
Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test
Overall Number of Participants Analyzed 143
Mean (Full Range)
Unit of Measure: units on a scale
24
(22 to 28)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title [Not Specified]
Hide Arm/Group Description Adverse Events were not collected for the 143 participants
All-Cause Mortality
[Not Specified]
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
[Not Specified]
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
[Not Specified]
Affected / at Risk (%)
Total   0/0 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sarah Hashim Ali Hussein
Organization: Aarhus University Hospital
Phone: 0045 42660308
EMail: sarsuri@hotmail.com
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01564953    
Other Study ID Numbers: M-20110280
First Submitted: March 26, 2012
First Posted: March 28, 2012
Results First Submitted: May 31, 2015
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017