Tracing Changed Production of Red Blood Cells

In competitive sport, it is illegal to manipulate erythropoiesis. Manipulated erythropoiesis can indirectly be identified by atypical fluctuations in key haematological variables. However, this method also has limitations and as it is known that some athletes still manipulate erythropoiesis it is necessary to develop new and more sensitive detection methods.

The primary purpose of the study is to examine the importance of altered erythropoiesis for surface and intracellular erythrocyte proteins, the number of immature reticulocytes, and for the haematological characteristics of the erythrocyte, such as volume, haemoglobin concentration and concentration of glycosylated haemoglobin, to assess whether these can be used to identify changed erythropoiesis. Furthermore, the aim is to examine whether these parameters are affected by freezer storage of erythrocytes.

Study Overview

• Status: Completed
• Conditions: Erythrocytosis; Erythropoiesis Abnormal
• Intervention / Treatment: Drug: Recombinant human erythropoietin

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Nutrition, Exercise and Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy men
• 18-40 years
• physical fitness rating more than 50ml/kg/min
• non-smokers
• blood pressure <130/90 mmHg
• hemoglobin concentration 7-10.5 mM.

Exclusion Criteria:

• Blood donor who has donated blood within the last three months
• Participation in other concurrent clinical trials
• To participate in competitive sport during or three months after the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Recombinant human erythropoietin treatment three times per week for three weeks	Drug: Recombinant human erythropoietin; Recombinant human erythropoietin treatment three times per week for three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in CD71 expression	Treatment induced changes in CD71 expression on red blood cells	In the period from two weeks before treatment to three weeks after treatment
Changes in CD35 expression	Treatment induced changes in CD35 expression on red blood cells	In the period from two weeks before treatment to three weeks after treatment
Changes in CD47 expression	Treatment induced changes in CD47 expression on red blood cells	In the period from two weeks before treatment to three weeks after treatment
Changes in CD55 expression	Treatment induced changes in CD55 expression on red blood cells	In the period from two weeks before treatment to three weeks after treatment
Changes in CD59 expression	Treatment induced changes in CD59 expression on red blood cells	In the period from two weeks before treatment to three weeks after treatment
Changes in RNA expression	Treatment induced changes in RNA expression in red blood cells	In the period from two weeks before treatment to three weeks after treatment
Changes in Mean Cell Volume	Treatment induced changes in Mean Cell Volume distribution of red blood cells	In the period from two weeks before treatment to three weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in HbA1c	Treatment induced changes in HbA1c content of red blood cells	In the period from two weeks before treatment to three weeks after treatment
Continous blood glucose levels	Continuous blood glucose level throughout the study	In the period from two weeks before treatment to three weeks after treatment
Changes in CD71 cryopreserved	CD71 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Changes in CD35 cryopreserved	CD35 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Changes in CD47 cryopreserved	CD47 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Changes in CD55 cryopreserved	CD55 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Changes in CD59 cryopreserved	CD59 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Changes in RNA cryopreserved	RNA expression inred blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Changes in Mean Cell Volume cryopreserved	Mean Cell Volume distribution of red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Changes in Ferritin	Quantification of plasma ferritin concentration	In the period from two weeks before treatment to three weeks after treatment
Changes in Complete Blood Count on Advia	Complete Blood Count analysis on the Advia 2120i instrument	In the period from two weeks before treatment to three weeks after treatment
Changes in Complete Blood Count on Sysmex	Complete Blood Count analysis on the Sysmex XN-450 instrument	In the period from two weeks before treatment to three weeks after treatment
Changes in Complete Blood Count on Advia - cryopreserved	Complete Blood Count analysis on the Advia 2120i instrument before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Changes in Complete Blood Count on Sysmex - cryopreserved	Complete Blood Count analysis on the Sysmex XN-450 instrument before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Changes in ALAS 2	Quantification of ALAS 2 in dried blood spots stored at room temperature, -20C and -80C	Up to 5 years
Changes in CA1	Quantification of CA1 in dried blood spots	Up to 5 years
Changes in SLC4a1	Quantification of SLC4a1 in dried blood spots	Up to 5 years
Changes in CD71 in dried blood spots	Quantification of CD71 in dried blood spots	Up to 5 years
Changes in FECH	Quantification of FECH in dried blood spots	Up to 5 years
Changes in Band 3	Quantification of Band 3 in dried blood spots	Up to 5 years
Changes in blood volume	Measurement of blood volume by CO rebreathing	Within 14 days before treatment and within 14 days after treatment

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Jacob Bejder, Ph.D., University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Polycythemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: H-20064997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No