NCT01553409

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Typical duration 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
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

March 12, 2012

Last Update Submit

May 7, 2014

Conditions

Hypertension

Keywords

HypertensionFerritinPhlebotomyBlood donation

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    seated blood pressure will be measured baseline and after 3 months by trained professionals

    3 months

Secondary Outcomes (1)

  • blood pressure

    12 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin Blutspende Campus Mitte

Berlin, 10117, Germany

Location

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

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Andreas Michalsen, Prof. Dr.

    Charite University

    PRINCIPAL INVESTIGATOR

  • Abdulgabar Salama, Prof. Dr.

    Charite University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of clinical naturopathic medicine

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 14, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

DE(1)