NCT04965961

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

June 28, 2021

Last Update Submit

November 28, 2023

Conditions

Sports Drug Abuse

Keywords

erythropoeitindoping

Outcome Measures

Primary Outcomes (3)

  • Change in maximal oxygen uptake

    Change from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test.

    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.

    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.

    Change from baseline to 3 days after last injection

Study Arms (2)

Recombinant human erythropoietin treatment

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

EPODRUG

Please refer to the arm description

Recombinant human erythropoietin treatment
Control group - saline injectionOTHER

Please refer to the arm description

Control group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Relative maximum oxygen uptake (VO2-max) of at least 50 ml O2/min/kg for male participants and 45 ml O2/min/kg for female participants

You may not qualify if:

  • Age
  • Insufficient fitness level
  • Blood donation 3 months prior to enrollment
  • Altitude exposure 2 months before enrollment
  • Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • Breenfeldt Andersen A, Bejder J, Bonne TC, Graae J, Seier S, Nordsborg NB. Changes in Immature Reticulocytes Aid the Indirect Detection of Microdose Recombinant Erythropoietin Use in Men and Women. Med Sci Sports Exerc. 2023 Sep 1;55(9):1695-1705. doi: 10.1249/MSS.0000000000003197. Epub 2023 Apr 24.

    PMID: 37095637DERIVED

  • Breenfeldt Andersen A, Graae J, Bejder J, Bonne TC, Seier S, Debertin M, Eibye K, Hostrup M, Nordsborg NB. Microdoses of Recombinant Human Erythropoietin Enhance Time Trial Performance in Trained Males and Females. Med Sci Sports Exerc. 2023 Feb 1;55(2):311-321. doi: 10.1249/MSS.0000000000003052. Epub 2022 Nov 1.

    PMID: 36317927DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
An algorithm was created using randomizer.org
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Explorative
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Department

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 16, 2021

Study Start

August 28, 2019

Primary Completion

May 17, 2021

Study Completion

January 1, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DK(1)