Impact of Iron Injection on Blood Donation

Study Overview
=================
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

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).

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

Conditions
-----------------
Iron Deficiency

Intervention / Treatment
-----------------
* Other: iron injection
* Other: saline solution injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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