Impact of Iron Injection on Blood Donation

Iron Deficiency Clinical Trial

— FERDOP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03014921
• Other study ID #: 2016-00324
• Status: Active, not recruiting
• Phase: N/A
• First received: December 23, 2016
• Last updated: January 6, 2017
• Start date: December 2016
• Est. completion date: April 2017

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissethics
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Other:
• iron injection
Injection of a 250mL saline solution added with 500mg of iron (Ferinject)
• saline solution injection
Injection of a 250mL saline solution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nicolas Leuenberger	Centre Hospitalier Universitaire Vaudois

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum ferritin level variations due to iron injection or blood donation	measurements will be done in ug/l	8 weeks	No
Secondary	Hemoglobin level variations due to iron injection or blood donation	measurements will be done in g/dL	8 weeks	No
Secondary	Reticulocyte% variations due to iron injection or blood donation	measurements will be done in %	8 weeks	No