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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01553409
First received: March 12, 2012
Last updated: May 7, 2014
Last verified: May 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
Study Completion Date: May 2014
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553409

Locations
Germany
Charité Universitätsmedizin Berlin Blutspende Campus Mitte
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: May 7, 2014
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014