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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
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Nicolas Leuenberger, Centre Hospitalier Universitaire Vaudois

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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
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 : December 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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)




Primary Outcome Measures :
  1. Serum ferritin level variations due to iron injection or blood donation [ Time Frame: 8 weeks ]
    measurements will be done in ug/l


Secondary Outcome Measures :
  1. Hemoglobin level variations due to iron injection or blood donation [ Time Frame: 8 weeks ]
    measurements will be done in g/dL

  2. Reticulocyte% variations due to iron injection or blood donation [ Time Frame: 8 weeks ]
    measurements will be done in %



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Nicolas Leuenberger, PhD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03014921    
Other Study ID Numbers: 2016-00324
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases