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NCT05078138 · ClinicalTrials.gov registry record · Phase 4
Impact of Erythropoietin on Hematological Adaptations and Physical Performance
A Phase 4 study of Physical Performance and Exercise-Induced Anemia, sponsored by United States Army Research Institute of Environmental Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT05078138: Completed Phase 4 study of Physical Performance and Exercise-Induced Anemia, sponsored by United States Army Research Institute of Environmental Medicine.
NCT05078138 is a Phase 4 study of Physical Performance and Exercise-Induced Anemia that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 8 participants, below the 3,608-participant average among 6 other Physical Performance trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05078138, a Phase 4 study of Physical Performance and Exercise-Induced Anemia, has completed, sponsored by United States Army Research Institute of Environmental Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Negative hematological adaptations due to prolonged periods of strenuous physical activity may, in part, contribute to declines in physical performance during military operations. Exogenous erythropoietin (EPO) is a potential intervention that may be used to maintain hemoglobin (hgb), hematocrit (Hct), and physical performance during periods of high physical activity. The objective of the current study is to determine the ability of EPO to maintain hgb, Hct, and physical performance compared to baseline measures. Additionally, EPO may result in non-hematological adaptations which increase mitochondria biogenesis and alter substrate oxidation. As such, this study will also assess the influence of EPO on whole-body and skeletal muscle substrate oxidation. Eight healthy physically active individuals will be recruited to participate in this longitudinal trial. After exercise practice sessions, volunteers will complete baseline physical performance (time trial) and substrate oxidation testing. Participants will then receive EPO injections 3 times per week for 4 weeks. Diet and exercise will be controlled during the injection period. Participants will undergo four weeks of an intense physical training exercise program. Every seventh day during the injection period a safety blood sample, assessing hematocrit, will be drawn, and participants will complete a 5 km time trial to determine the time course of changes in physical performance can be detected. After the 4 weeks of EPO injections volunteers will complete the same physical performance and substrate oxidation testing. Substrate oxidation will be assessed during 90-min steady-state load carriage (30% body mass) exercise on a treadmill at 55 ± 5% of VO2peak. 6-6-\[2H2\] glucose tracer technique and indirect calorimetry will be used measure substrate oxidation. Muscle biopsies will be performed to measure muscle glycogen, enzyme activity, and molecular markers of metabolism and inflammation before, and immediately and 3-
Primary Outcome
Determine the effects of EPO on hemoglobin concentration compared to baseline during 4 weeks of overtraining.
Conditions Studied
Interventions
- DRUG Epoetin Alfa
Study Locations (1)
Massachusetts
- US Army Research Institute of Environmental Medicine - Natick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2023-04-01 |
| Phase | Phase 4 |
What the finished NCT05078138 record still lists
NCT05078138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 3,608-participant average among 6 other Physical Performance trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Physical Performance appearing as the primary indexed condition, and to 1 intervention - of which Epoetin Alfa is the first listed.
NCT05078138 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05078138 about?
NCT05078138 is a clinical study titled "Impact of Erythropoietin on Hematological Adaptations and Physical Performance". Negative hematological adaptations due to prolonged periods of strenuous physical activity may, in part, contribute to declines in physical performance during military operations. Exogenous erythropoietin (EPO) is a potential intervention that may be used to maintain hemoglobin (hgb), hematocrit (Hc...
What is the current status of trial NCT05078138?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2021-09-01. Estimated completion is 2023-04-01.
What conditions does trial NCT05078138 study?
This clinical trial studies the following conditions: Physical Performance, Exercise-Induced Anemia.
What interventions are being tested in trial NCT05078138?
The interventions under investigation include: Epoetin Alfa (DRUG).
Who is sponsoring clinical trial NCT05078138?
This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05078138 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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