CD71 in Dried Blood Spots in Healthy Males
- Conditions
- Healthy Athletes
- Interventions
- Other: Normal Saline
- Registration Number
- NCT04073849
- Lead Sponsor
- Sports Medicine Research and Testing Laboratory
- Brief Summary
Understand the effect of recombinant EPO (rEPO) boosting and microdosing on the hematological module of the Athlete Biological Passport (ABP)
* Measure the change in CD71 longitudinally in subjects from both cohorts
* Assess whether rEPO administration can be detected in a dried blood spot (DBS) using recent advances in analytical methodologies
* Compare windows of rEPO detection using both Athlete Biological Passport models and direct detection using analytical methods in urine, blood, and DBS
- Detailed Description
Despite being banned by the World Anti-Doping Agency, blood doping is a common method of performance enhancement used by athletes wishing to gain an unfair advantage over their competition. A common way to achieve this increase is by using erythropoiesis stimulating agents (ESA's), namely recombinant erythropoietin (rEPO). Though laboratory tests have been developed for the direct detection of all known isoforms of exogenously administered ESAs in both urine and blood, athletes have found ways to circumvent these testing measures using techniques such as microdosing.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Active individuals, preferably those that participate regularly in endurance athletics either for sport or for leisure, between the ages of 18 and 45
- Participants should have ferritin > 35 ng/mL and transferrin saturation > 20% at the time of enrollment
Individuals currently enrolled in a registered testing pool for anti-doping purposes
- Individuals with the intent to compete in sanctioned athletic events during the study period
- Unwillingness to provide urine samples or blood samples
- Not actively exercising
- Individuals who show a high risk for MI/CAD, stroke, CHF, and venous thromboembolism (VTE)., as defined by the Principal Investigator
- Individuals with known drug allergies
- Individuals with EKG abnormalities, as determined by the Principal Investigator
- Individuals who have chronic kidney disease, HIV, cancer, hepatitis B, hepatitis C, or are planning surgery during the study
- Individuals with history of acute or chronic medical or psychiatric condition
- GFR (Creatinine clearance) <60 mL/min
- Ferritin >270 ng/mL
- Individuals who have a baseline hemoglobin concentration greater than 15.5 g/dL or a baseline hematocrit above 47%
- Individuals with blood or iron disorders, including polycythemia, hemochromatosis, anemia, or iron-deficiency anemia
- Individuals with a history of bleeding or bone marrow aplasia
- Individuals who are diabetic or with a history of cardiac or hepatic disease or history of drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A EPOGEN® (epoetin alfa) EPOGEN® (epoetin alfa) Study Drug Epoetin Alfa (EPOGEN®) 40 IU / kg dose during boosting phase, delivered s.c.; 8 injections 900 IU dose during microdosing, delivered i.v.; 6 injections Cohort B Normal Saline Saline 40 IU / kg dose during boosting phase, delivered s.c.; 8 injections 900 IU dose during microdosing, delivered i.v.; 6 injections
- Primary Outcome Measures
Name Time Method Reticulocyte percentage (Ret%) 8 months Ret% will be measured during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO
Immature reticuocyte fraction 8 months The immature reticulocyte fraction (IRF) will be measured during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO.
CD71 (transferrin receptor) concentration 8 months CD71 concentration will be measured during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO. These data, especially when comparing to the variability in CD71 in the placebo cohort, may be extrapolated in the anti-doping framework to detect rEPO abuse by athletes.
Hemogloblin concentration 8 months Hemoglobin concentration will be measured during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO
Calculated OFF-score 8 months Calculated using the formula: OFF-score = Hgb - 60\*√Ret%, OFF-score will be calculated from each collection during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO
- Secondary Outcome Measures
Name Time Method Window of detection (detectability time) following rEPO use 12 months The length of time (following both the subcutaneous 'boosting' phase and the intravenous 'microdosing' phase) that rEPO use is evident will be assessed. This will be assessed using different criteria:
1. Direct detection of the rEPO drug in urine, serum (and/or plasma), and dried blood spots
2. b. Athlete Biological Passport adaptive modelAnalytical detection of rEPO in a dried blood spot 12 months Dried blood spot samples will be extracted and analyzed using analytical techniques (namely SAR-PAGE, SDS-PAGE, IEF-PAGE, or others) employed by the laboratory for the direct detection of rEPO.
Trial Locations
- Locations (1)
Sports Medicine Research and Testing Laboratory
🇺🇸Salt Lake City, Utah, United States