Effect of Blood Donation on Blood Pressure, Iron Metabolism, Oxidative Stress

This study is currently recruiting participants.
Verified March 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01553409
First received: March 12, 2012
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

The investigators want to investigate the effects of blood donation to blood pressure, to iron metabolism and oxidative stress.

There are results of other studies that show, that there is a positive effect of blood donation to high blood pressure, iron metabolism and oxidative stress.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study on the Effects of Blood Donation on Blood Pressure, Iron Metabolism and Oxidative Stress

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    seated blood pressure will be measured baseline and after 3 months by trained professionals


Secondary Outcome Measures:
  • blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    seated blood pressure will be measured baseline and after 12 months by trained professionals


Biospecimen Retention:   Samples Without DNA

regular blood donation is done and from blood, that is taken for blood tests by the blood donation center any there are made blood tests of lipid metabolism, iron metabolism and antioxidative stress


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The regular application flow of blood donation at that blood bank of Charité is not disturbed. There are only some more questions and measurement of blood pressure, iron metabolism, fat metabolism and oxidative stress.

No extra puncture of the vein is necessary.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

female and male from 18 years to 65 years, who are able and want to donate blood for the first time or after one year break to the last blood donation

Criteria

Inclusion Criteria:

  • first time donating blood or after a break of 12 months to last blood donation
  • voluntary attending blood donation and study
  • fulfilling the criteria of the blood donation center

Exclusion Criteria:

  • criteria of the blood donation center (e. g. low haemoglobin, fever, acute infection, having spent in tropical countries for the last months,general bad health condition,...)
  • missing informed consent to the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553409

Contacts
Contact: Elke Rudat 0049450529665032 elke.rudat@charite.de

Locations
Germany
Charité Universitätsmedizin Berlin Blutspende Campus Mitte Recruiting
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Andreas Michalsen, Prof. Dr. Charite University
Principal Investigator: Abdulgabar Salama, Prof. Dr. Charite University
  More Information

No publications provided

Responsible Party: Andreas Michalsen, Chair of clinical naturopathic medicine, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01553409     History of Changes
Other Study ID Numbers: 89834103
Study First Received: March 12, 2012
Last Updated: March 21, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Hypertension
Ferritin
Phlebotomy
Blood donation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014