An interventional study of EPO and Control group - saline injection in Sports Drug Abuse, sponsored by University of Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Other
Recombinant human erythropoietin (rHuEPO) regimen enhances maximal oxygen consumption (VO2max), but the effect of micro-doses on maximal and submaximal performance is not clear and detection of micro-doses is difficult with current methods. This study investigated whether micro-doses of rHuEPO enhances maximal and endurance performance in males and females.
In a randomized, double-blind, placebo-controlled design, 48 trained adults (24 females, 24 males) receive either recombinant human erythropoietin (rHuEPO; epoetin-β, 9 IU/kg, n = 24, (12 females, 12 males)) or placebo (0,9% NaCl, n = 24, (12 females, 12 males)) three times per week for four weeks. Before the intervention, time trial performance and maximal oxygen uptake will be assessed. Three and five days after the last injection, time trial performance and maximal oxygen uptake will be determined to assess the effect of the rHuEPO administration. In addition, total hemoglobin mass and intravascular volumes will be determined via the carbon monoxide rebreathing method in duplicate measures.
University of Copenhagen is the lead sponsor of 465 studies on the registry; 63 are open to participants now.
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Participants receive intravenous injections of 9 International Units per kg bodyweight epoetin-β (NeoRecormon, Roche, Mannheim, Germany) three times per week for four weeks on non-consecutive days. Subjects receive tablets with 80mg iron (Tardyferon, Pierre Fabre Pharme GmbH, Freiburg, Germany) to ensure sufficient iron stores for the expected increase in erythropoeisis.
Drug: EPO
Participants receive intravenous injections of \~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days.
Other: Control group - saline injection
Please refer to the arm description
Please refer to the arm description
Change in maximal oxygen uptake
Change from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test.
Time frame: Change from baseline to 5 days after last injection
Change in time trial performance
Change from baseline endurance exercise performance 3 days after last injection. Measured via a preloaded 400 kcal time-trial.
Time frame: Change from baseline to 3 days after last injection
Change in total hemoglobin mass
Change from baseline total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method.
Time frame: Change from baseline to 3 days after last injection
Plan to share: Undecided — Fully anonymous data can be shared with other researchers.
Ran from Aug 2019 to primary completion in May 2021, 20 months.
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This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epoetin Alfa