Impact of Iron Injection on Blood Donation (FERDOP)

January 6, 2017 updated by: Nicolas Leuenberger

Effet de l'Injection de Fer Sur la Donation Sanguine, étude randomisée et contrôlée

This trial study and compare in blood and urinary matrices the impact of an iron injection on proteins involved in iron metabolism during a blood donation. The goal is to study the impact of an iron injection on detection markers of a blood donation in the anti-doping field

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study aim to investigate the impact of an iron injection on the proteins involved in iron metabolism during blood donation and to compare the blood and urinary matrix. A messenger RNA profiling will be performed as well. The goal is to investigate the impact of iron injection on the markers of blood donation detection in the anti-doping field.

The study will take place over a period of 8 weeks.

Volunteers will be randomly assigned to two groups. Randomization will be provided by a software made for this purpose. An injection of 500 mg of iron in 250mL of saline solution or a placebo injection containing only the saline solution will be performed. Standard blood sampling (in the arm) and finger prick blood sampling will be carried out. After that, 500 mL blood donation will be done. Standard blood sampling and finger prick blood sampling will be performed before and after the donation.

The study will be done in "simple blind", meaning that volunteers will not know if they get iron or saline solution.

On the days of iron or saline solution injection and blood donation, blood sampling will be done up to 12 hours after the injection. After that, blood sampling will be scheduled up to 30 days after blood donation at a rate of once a day (except for the weekends).

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male between 20 and 35 yo
  • BMI between 18 and 30
  • Ferritin < 50ug/l
  • Transferrin saturation < 20 if ferritin between 20 and 50ug/l

Exclusion Criteria:

  • high level athlete
  • blood donation within 6 months before the study
  • liver disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo injection group
saline solution injection as placebo
Other: saline solution injection
Injection of a 250mL saline solution
Active Comparator: iron injection group
iron injection
Other: iron injection
Injection of a 250mL saline solution added with 500mg of iron (Ferinject)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum ferritin level variations due to iron injection or blood donation
Time Frame: 8 weeks
measurements will be done in ug/l
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin level variations due to iron injection or blood donation
Time Frame: 8 weeks
measurements will be done in g/dL
8 weeks
Reticulocyte% variations due to iron injection or blood donation
Time Frame: 8 weeks
measurements will be done in %
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicolas Leuenberger

Collaborators

Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

December 23, 2016

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Estimate)

January 9, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-00324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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