Trial Outcomes & Findings for Impact of Erythropoietin on Hematological Adaptations and Physical Performance (NCT NCT05078138)

NCT ID: NCT05078138

Last Updated: 2025-04-18

Results Overview

Determine the effects of EPO on hemoglobin concentration compared to baseline during 4 weeks of overtraining.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 8 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2025-04-18

Participant Flow

Participant milestones

Measure	Exogenous Erythropoietin Recombinant human Erythropoietin subcutaneous injection of 50 IU/kg body mass 3 times per week for 4 week Epoetin Alfa: Subcutaneous injection of Epoetin Alfa 3 times per week for 4 weeks
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Erythropoietin on Hematological Adaptations and Physical Performance

Baseline characteristics by cohort

Measure	Exogenous Erythropoietin n=8 Participants Recombinant human Erythropoietin subcutaneous injection of 50 IU/kg body mass 3 times per week for 4 week Epoetin Alfa: Subcutaneous injection of Epoetin Alfa 3 times per week for 4 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	20 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
VO2peak	44 ml/kg/min STANDARD_DEVIATION 2 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Determine the effects of EPO on hemoglobin concentration compared to baseline during 4 weeks of overtraining.

Outcome measures

Measure	Exogenous Erythropoietin n=8 Participants Recombinant human Erythropoietin subcutaneous injection of 50 IU/kg body mass 3 times per week for 4 week Epoetin Alfa: Subcutaneous injection of Epoetin Alfa 3 times per week for 4 weeks
Concentration of Hemoglobin	1.46 g/dL Standard Deviation 0.71

PRIMARY outcome

Timeframe: 4 weeks

Determine the time course change in time to complete a 5 km treadmill run with EPO compared to baseline.

Outcome measures

Measure	Exogenous Erythropoietin n=8 Participants Recombinant human Erythropoietin subcutaneous injection of 50 IU/kg body mass 3 times per week for 4 week Epoetin Alfa: Subcutaneous injection of Epoetin Alfa 3 times per week for 4 weeks
Time to Complete 5 km Time Trial	-166 seconds Standard Deviation 143

SECONDARY outcome

Timeframe: 4 weeks

Assess the influence of EPO non-hematological adaptation (carbohydrate and fat oxidation rates and skeletal muscle substrate oxidation and glucose turnover rates) following 4 weeks of overtraining compared to baseline.

Outcome measures

Measure	Exogenous Erythropoietin n=8 Participants Recombinant human Erythropoietin subcutaneous injection of 50 IU/kg body mass 3 times per week for 4 week Epoetin Alfa: Subcutaneous injection of Epoetin Alfa 3 times per week for 4 weeks
Rate of Fat Oxidation	0.08 g/min Standard Deviation 0.16

Adverse Events

Exogenous Erythropoietin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lee Margolis

USARIEM

Phone: 508-206-2335

Email: lee.m.margolis.civ@health.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place