Status:
COMPLETED
CD71 in Dried Blood Spots in Healthy Males
Lead Sponsor:
Sports Medicine Research and Testing Laboratory
Conditions:
Healthy Athletes
Eligibility:
MALE
18-45 years
Phase:
EARLY_PHASE1
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 f...
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04073849
Start Date
July 15 2019
End Date
December 1 2020
Last Update
March 17 2021
Active Locations (1)
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1
Sports Medicine Research and Testing Laboratory
Salt Lake City, Utah, United States, 84108