Impact of Iron Injection on Blood Donation

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03014921

Acronym

FERDOP

Enrollment

Registered

2017-01-09

Start date

2016-12-31

Completion date

2017-04-30

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

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).

Interventions

OTHERiron injection

Injection of a 250mL saline solution added with 500mg of iron (Ferinject)

OTHERsaline solution injection

Injection of a 250mL saline solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 35 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 %

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026