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

Sponsor

University of Copenhagen (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04965961

Collaborator

(none)

Enrollment

Location

Arms

39.1

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sports Drug Abuse	Drug: EPO Other: Control group - saline injection	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

ExplorativeExplorative

Masking:

Double (Participant, Investigator)

Masking Description:

An algorithm was created using randomizer.org

Primary Purpose:

Other

Official Title:

Plasma and Exosome Proteomic Changes Associated With Augmented Erythropoiesis and Muscle Contractions.

Actual Study Start Date :

Aug 28, 2019

Actual Primary Completion Date :

May 17, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: EPO Please refer to the arm description
Placebo Comparator: 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.	Other: Control group - saline injection Please refer to the arm description

Arm

Intervention/Treatment

Experimental: 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.

Drug: EPO

Please refer to the arm description

Placebo Comparator: 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.

Other: Control group - saline injection

Please refer to the arm description

Outcome Measures

Primary Outcome Measures

Change in maximal oxygen uptake [Change from baseline to 5 days after last injection]
Change from baseline maximal aerobic capacity 5 days after last injection. Measured via an exhaustive incremental cycle ergometer test.
Change in time trial performance [Change from baseline to 3 days after last injection]
Change from baseline endurance exercise performance 3 days after last injection. Measured via a preloaded 400 kcal time-trial.
Change in total hemoglobin mass [Change from baseline to 3 days after last injection]
Change from baseline total hemoglobin mass 3 days after last injection. Measured by the carbon monoxide rebreathing method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition, Exercise and Sports	Copenhagen		Denmark	2100

Sponsors and Collaborators

University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nikolai Nordsborg, Professor, Head of Department, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT04965961

Other Study ID Numbers:

H-18013069

First Posted:

Jul 16, 2021

Last Update Posted:

Jul 16, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nikolai Nordsborg, Professor, Head of Department, University of Copenhagen

erythropoeitin

doping

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Jul 16, 2021