<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03014921</url>
  </required_header>
  <id_info>
    <org_study_id>2016-00324</org_study_id>
    <nct_id>NCT03014921</nct_id>
  </id_info>
  <brief_title>Impact of Iron Injection on Blood Donation</brief_title>
  <acronym>FERDOP</acronym>
  <official_title>Effet de l'Injection de Fer Sur la Donation Sanguine, étude randomisée et contrôlée</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nicolas Leuenberger</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial study and compare in blood and urinary matrices the impact of an iron injection on&#xD;
      proteins involved in iron metabolism during a blood donation. The goal is to study the impact&#xD;
      of an iron injection on detection markers of a blood donation in the anti-doping field&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aim to investigate the impact of an iron injection on the proteins involved in&#xD;
      iron metabolism during blood donation and to compare the blood and urinary matrix. A&#xD;
      messenger RNA profiling will be performed as well. The goal is to investigate the impact of&#xD;
      iron injection on the markers of blood donation detection in the anti-doping field.&#xD;
&#xD;
      The study will take place over a period of 8 weeks.&#xD;
&#xD;
      Volunteers will be randomly assigned to two groups. Randomization will be provided by a&#xD;
      software made for this purpose. An injection of 500 mg of iron in 250mL of saline solution or&#xD;
      a placebo injection containing only the saline solution will be performed. Standard blood&#xD;
      sampling (in the arm) and finger prick blood sampling will be carried out. After that, 500 mL&#xD;
      blood donation will be done. Standard blood sampling and finger prick blood sampling will be&#xD;
      performed before and after the donation.&#xD;
&#xD;
      The study will be done in &quot;simple blind&quot;, meaning that volunteers will not know if they get&#xD;
      iron or saline solution.&#xD;
&#xD;
      On the days of iron or saline solution injection and blood donation, blood sampling will be&#xD;
      done up to 12 hours after the injection. After that, blood sampling will be scheduled up to&#xD;
      30 days after blood donation at a rate of once a day (except for the weekends).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum ferritin level variations due to iron injection or blood donation</measure>
    <time_frame>8 weeks</time_frame>
    <description>measurements will be done in ug/l</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin level variations due to iron injection or blood donation</measure>
    <time_frame>8 weeks</time_frame>
    <description>measurements will be done in g/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reticulocyte% variations due to iron injection or blood donation</measure>
    <time_frame>8 weeks</time_frame>
    <description>measurements will be done in %</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>placebo injection group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>saline solution injection as placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iron injection group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>iron injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>iron injection</intervention_name>
    <description>Injection of a 250mL saline solution added with 500mg of iron (Ferinject)</description>
    <arm_group_label>iron injection group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>saline solution injection</intervention_name>
    <description>Injection of a 250mL saline solution</description>
    <arm_group_label>placebo injection group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male between 20 and 35 yo&#xD;
&#xD;
          -  BMI between 18 and 30&#xD;
&#xD;
          -  Ferritin &lt; 50ug/l&#xD;
&#xD;
          -  Transferrin saturation &lt; 20 if ferritin between 20 and 50ug/l&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  high level athlete&#xD;
&#xD;
          -  blood donation within 6 months before the study&#xD;
&#xD;
          -  liver disorder&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Nicolas Leuenberger</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014921
org study id: 2016-00324
nct id: NCT03014921
lead sponsor: 
collaborator: 
has dmc: Yes
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
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).
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Serum ferritin level variations due to iron injection or blood donation
time frame: 8 weeks
description: measurements will be done in ug/l
measure: Hemoglobin level variations due to iron injection or blood donation
time frame: 8 weeks
description: measurements will be done in g/dL
measure: Reticulocyte% variations due to iron injection or blood donation
time frame: 8 weeks
description: measurements will be done in %
arm group label: placebo injection group
arm group type: Placebo Comparator
description: saline solution injection as placebo
arm group label: iron injection group
arm group type: Active Comparator
description: iron injection
intervention type: Other
intervention name: iron injection
description: Injection of a 250mL saline solution added with 500mg of iron (Ferinject)
arm group label: iron injection group
intervention type: Other
intervention name: saline solution injection
description: Injection of a 250mL saline solution
arm group label: placebo injection group
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Nicolas Leuenberger
investigator title: PhD
mesh term: Iron Deficiencies
sharing ipd: No