FERDOP: Impact of Iron Injection on Blood Donation

Sponsor

Nicolas Leuenberger (Other)

Overall Status

Unknown status

CT.gov ID

NCT03014921

Collaborator

Centre Hospitalier Universitaire Vaudois (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency	Other: iron injection Other: saline solution injection	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Official Title:

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

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Apr 1, 2017

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Serum ferritin level variations due to iron injection or blood donation [8 weeks]
measurements will be done in ug/l

Secondary Outcome Measures

Hemoglobin level variations due to iron injection or blood donation [8 weeks]
measurements will be done in g/dL
Reticulocyte% variations due to iron injection or blood donation [8 weeks]
measurements will be done in %

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nicolas Leuenberger
Centre Hospitalier Universitaire Vaudois

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nicolas Leuenberger, PhD, Centre Hospitalier Universitaire Vaudois

ClinicalTrials.gov Identifier:

NCT03014921

Other Study ID Numbers:

2016-00324

First Posted:

Jan 9, 2017

Last Update Posted:

Jan 9, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Anemia, Iron-Deficiency

Study Results

No Results Posted as of Jan 9, 2017