NCT01564953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

March 6, 2017

Completed
Last Updated

March 6, 2017

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

March 26, 2012

Results QC Date

May 31, 2015

Last Update Submit

January 13, 2017

Conditions

Keywords

vitamin DcalciummagnesiumCOPDQoL

Outcome Measures

Primary Outcomes (1)

  • Serum Vitamin D

    vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L

    one year

Secondary Outcomes (4)

  • Lung Function Test

    one year

  • Serum Magnesium

    One year

  • Serum Calcium

    One year

  • Quality of Life

    One year

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients from the Department Of Resoiratory Diseases, Aarhus University Hospital

You may qualify if:

  • COPD-patients
  • Unchanged medical treatment for COPD for the last 4 weeks
  • Outpatients
  • adults over 40 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Sarah Hashim Ali Hussein
Organization
Aarhus University Hospital

Study Officials

  • Ronald Dahl, Professor

    Allergy Centre, Odense University Hospital

    STUDY DIRECTOR
  • Sarah HA Hussein, MD

    Department of Respiratory Diseases, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

March 6, 2017

Results First Posted

March 6, 2017

Record last verified: 2013-01

Data Sharing

IPD Sharing
Will share

Publish as paper in Scientific journal

Locations