Effect of Blood Donation on Blood Pressure, Iron Metaboli... | NCT01553409

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

NCT01553409

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

May 8, 2014Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Hypertension

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Mar 12, 2012

First Submission Date that Met QC Criteria

Mar 13, 2012

First Posted Date

Mar 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2014

Last Update Posted Date

May 8, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andreas Michalsen, Chair of clinical naturopathic medicine, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood pressure	seated blood pressure will be measured baseline and after 3 months by trained professionals	3 months

Secondary Outcomes

Measure	Description	Time Frame
blood pressure	seated blood pressure will be measured baseline and after 12 months by trained professionals	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Michalsen, Prof. Dr.	Charite University	Principal Investigator
Abdulgabar Salama, Prof. Dr.	Charite University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Universitätsmedizin Berlin Blutspende Campus Mitte		Berlin		10117	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided