Sports Medicine Research and Testing Laboratory
Salt Lake City, Utah, 84108, United States
NCT Number: NCT04073849
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
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Notify Me18 year–45 year
Male
Interventional
Early Phase 1
Salt Lake City, Utah, 84108, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Active individuals, preferably those that participate regularly in endurance athletics either for sport or for leisure, between the ages of 18 and 45
Exclusion criteria
Individuals currently enrolled in a registered testing pool for anti-doping purposes
Active drug
Other names: erythropoietin, rEPO
Placebo
Other names: Saline
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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:
Time frame: 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.
Sports Medicine Research and Testing Laboratory
Industry
Evaluation of CD71 Expression in a Dried Blood Spot Following rEPO Administration
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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