Sports Drug Abuse
Conditions
Keywords
antidoping
Brief summary
The main objective of this research is to demonstrate the possible use of erythroferrone (ERFE) as a potential marker of recombinant human erythropoietin (rHuEpo) use to be included in the Athlete Biological Passport (PBA) developed by the World Anti-Doping Agency (WADA).
Interventions
DRUGEPREX
6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
DRUGsodium chloride AGUETTANT 0.9%
6 injections at 1ml in subcutaneous use
Sponsors
University of Milan School of Medicine
Centre d'Investigation Clinique Lyon (CIC)
Ecole Nationale de Ski et d'Alpinisme (ENSA)
Partnership for Clean Competition
Association Athletes For Transparency
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
3 different conditions: * Eprex 20 UI/kg * Eprex 50 UI/kg * Placebo
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Man between 18 and 49 years old * Beneficiary of a social protection scheme * Able to sign informed consent
Exclusion criteria
* Hematocrite\>50% or Hemoglobin\> 17d/dl or Ferritin\<30 ug/l * Hypersensitivity to the active substance or to any of the excipients ofEPREX * Erythroblastopenia already reported following treatment with erythropoietin * Uncontrolled hypertension * Any medication taken as part of a chronic treatment * Absence of stable or evolutionary pathology without treatment * History of convulsion or epilepsy * History of thrombotic vascular events * Large blood loss due to an accident, pathological condition or other similar situation. * Donation of blood or blood transfusion within three months prior to inclusion in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythroferrone | 12 measures in 29 days | dosage Erythroferrone from blood samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hbmass | 2 measures in 29 days | Measure of the total mass of hemoglobin |
Contacts
Primary ContactPierre SALLET, phD
Backup ContactCatherine MD CORNU, phD
Outcome results
None listed