Impact of Iron Injection on Blood Donation (FERDOP)
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|ClinicalTrials.gov Identifier: NCT03014921|
Recruitment Status : Unknown
Verified January 2017 by Nicolas Leuenberger, Centre Hospitalier Universitaire Vaudois.
Recruitment status was: Active, not recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency||Other: iron injection Other: saline solution injection||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effet de l'Injection de Fer Sur la Donation Sanguine, étude randomisée et contrôlée|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||April 2017|
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
Other: iron injection
Injection of a 250mL saline solution added with 500mg of iron (Ferinject)
- Serum ferritin level variations due to iron injection or blood donation [ Time Frame: 8 weeks ]measurements will be done in ug/l
- Hemoglobin level variations due to iron injection or blood donation [ Time Frame: 8 weeks ]measurements will be done in g/dL
- Reticulocyte% variations due to iron injection or blood donation [ Time Frame: 8 weeks ]measurements will be done in %