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Impact of Iron Injection on Blood Donation (FERDOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 23, 2016
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date January 9, 2017
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
Serum ferritin level variations due to iron injection or blood donation [ Time Frame: 8 weeks ]
measurements will be done in ug/l
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2017)
  • 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 %
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Iron Injection on Blood Donation
Official Title  ICMJE Effet de l'Injection de Fer Sur la Donation Sanguine, étude randomisée et contrôlée
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE Iron Deficiency
Intervention  ICMJE
  • Other: iron injection
    Injection of a 250mL saline solution added with 500mg of iron (Ferinject)
  • Other: saline solution injection
    Injection of a 250mL saline solution
Study Arms  ICMJE
  • Placebo Comparator: placebo injection group
    saline solution injection as placebo
    Intervention: Other: saline solution injection
  • Active Comparator: iron injection group
    iron injection
    Intervention: Other: iron injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 6, 2017)
19
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014921
Other Study ID Numbers  ICMJE 2016-00324
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicolas Leuenberger, Centre Hospitalier Universitaire Vaudois
Study Sponsor  ICMJE Nicolas Leuenberger
Collaborators  ICMJE Centre Hospitalier Universitaire Vaudois
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Vaudois
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP