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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

Tracking Information
First Submitted Date March 26, 2012
First Posted Date March 28, 2012
Results First Submitted Date May 31, 2015
Results First Posted Date March 6, 2017
Last Update Posted Date March 6, 2017
Study Start Date February 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2017)
Serum Vitamin D [ Time Frame: one year ]
vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L
Original Primary Outcome Measures
 (submitted: March 27, 2012)
Vitamin D [ Time Frame: measured at the time of the participation - no time frame ]
vitamin D measured by p-25-hydroxy-vitamin D2 + D3
Change History
Current Secondary Outcome Measures
 (submitted: January 13, 2017)
  • Lung Function Test [ Time Frame: one year ]
    Forced expiratory ventilation in 1 second, in percent of predicted
  • Serum Magnesium [ Time Frame: One year ]
    Serum magnesium in plasma, in mmol/L
  • Serum Calcium [ Time Frame: One year ]
    Serum ionized calcium, in mmol/L
  • Quality of Life [ Time Frame: 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).
Original Secondary Outcome Measures
 (submitted: March 27, 2012)
Lung Function Test [ Time Frame: measured at the time of the participation - no time frame ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:

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

Sampling Method Non-Probability Sample
Study Population Outpatients from the Department Of Resoiratory Diseases, Aarhus University Hospital
Condition Chronic Obstructive Pulmonary Disease (COPD)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Hashim Ali Hussein S, Nielsen LP, Konow Bøgebjerg 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 16, 2013)
143
Original Estimated Enrollment
 (submitted: March 27, 2012)
175
Actual Study Completion Date January 2013
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01564953
Other Study ID Numbers M-20110280
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Publish as paper in Scientific journal
Responsible Party University of Aarhus
Study Sponsor University of Aarhus
Collaborators Aarhus University Hospital
Investigators
Study Director: Ronald Dahl, Professor Allergy Centre, Odense University Hospital
Principal Investigator: Sarah HA Hussein, MD Department of Respiratory Diseases, Aarhus University Hospital
PRS Account University of Aarhus
Verification Date January 2013