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The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females

NCT ID: NCT04965961

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-28

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sports Drug Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Explorative
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
An algorithm was created using randomizer.org

Study Groups

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Recombinant human erythropoietin treatment

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.

Group Type EXPERIMENTAL

EPO

Intervention Type DRUG

Please refer to the arm description

Control group

Participants receive intravenous injections of \~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days.

Group Type PLACEBO_COMPARATOR

Control group - saline injection

Intervention Type OTHER

Please refer to the arm description

Interventions

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EPO

Please refer to the arm description

Intervention Type DRUG

Control group - saline injection

Please refer to the arm description

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Nikolai Nordsborg

Professor, Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Nutrition, Exercise and Sports

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 37095637 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36317927 (View on PubMed)

Other Identifiers

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H-18013069

Identifier Type: -

Identifier Source: org_study_id