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Completed

NCT Number: NCT05833477

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.

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Key information

Conditions

Erythrocytosis Erythropoiesis Abnormal Hematologic Diseases Hemic and Lymphatic Diseases Polycythemia

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recombinant human erythropoietin

Drug

Recombinant human erythropoietin treatment three times per week for three weeks

Primary outcomes

  1. Changes in CD71 expression

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Treatment induced changes in CD71 expression on red blood cells

  2. Changes in CD35 expression

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Treatment induced changes in CD35 expression on red blood cells

  3. Changes in CD47 expression

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Treatment induced changes in CD47 expression on red blood cells

  4. Changes in CD55 expression

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Treatment induced changes in CD55 expression on red blood cells

  5. Changes in CD59 expression

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Treatment induced changes in CD59 expression on red blood cells

  6. Changes in RNA expression

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Treatment induced changes in RNA expression in red blood cells

  7. Changes in Mean Cell Volume

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Treatment induced changes in Mean Cell Volume distribution of red blood cells

Secondary outcomes

  1. Changes in HbA1c

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Treatment induced changes in HbA1c content of red blood cells

  2. Continous blood glucose levels

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Continuous blood glucose level throughout the study

  3. Changes in CD71 cryopreserved

    Time frame: Cryopreserved cells are measured 6 months after sample collection

    CD71 expression on red blood cells before and after cryopreservation

  4. Changes in CD35 cryopreserved

    Time frame: Cryopreserved cells are measured 6 months after sample collection

    CD35 expression on red blood cells before and after cryopreservation

  5. Changes in CD47 cryopreserved

    Time frame: Cryopreserved cells are measured 6 months after sample collection

    CD47 expression on red blood cells before and after cryopreservation

  6. Changes in CD55 cryopreserved

    Time frame: Cryopreserved cells are measured 6 months after sample collection

    CD55 expression on red blood cells before and after cryopreservation

  7. Changes in CD59 cryopreserved

    Time frame: Cryopreserved cells are measured 6 months after sample collection

    CD59 expression on red blood cells before and after cryopreservation

  8. Changes in RNA cryopreserved

    Time frame: Cryopreserved cells are measured 6 months after sample collection

    RNA expression inred blood cells before and after cryopreservation

  9. Changes in Mean Cell Volume cryopreserved

    Time frame: Cryopreserved cells are measured 6 months after sample collection

    Mean Cell Volume distribution of red blood cells before and after cryopreservation

  10. Changes in Ferritin

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Quantification of plasma ferritin concentration

  11. Changes in Complete Blood Count on Advia

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Complete Blood Count analysis on the Advia 2120i instrument

  12. Changes in Complete Blood Count on Sysmex

    Time frame: In the period from two weeks before treatment to three weeks after treatment

    Complete Blood Count analysis on the Sysmex XN-450 instrument

  13. Changes in Complete Blood Count on Advia - cryopreserved

    Time frame: Cryopreserved cells are measured 6 months after sample collection

    Complete Blood Count analysis on the Advia 2120i instrument before and after cryopreservation

  14. Changes in Complete Blood Count on Sysmex - cryopreserved

    Time frame: Cryopreserved cells are measured 6 months after sample collection

    Complete Blood Count analysis on the Sysmex XN-450 instrument before and after cryopreservation

  15. Changes in ALAS 2

    Time frame: Up to 5 years

    Quantification of ALAS 2 in dried blood spots stored at room temperature, -20C and -80C

  16. Changes in CA1

    Time frame: Up to 5 years

    Quantification of CA1 in dried blood spots

  17. Changes in SLC4a1

    Time frame: Up to 5 years

    Quantification of SLC4a1 in dried blood spots

  18. Changes in CD71 in dried blood spots

    Time frame: Up to 5 years

    Quantification of CD71 in dried blood spots

  19. Changes in FECH

    Time frame: Up to 5 years

    Quantification of FECH in dried blood spots

  20. Changes in Band 3

    Time frame: Up to 5 years

    Quantification of Band 3 in dried blood spots

  21. Changes in blood volume

    Time frame: Within 14 days before treatment and within 14 days after treatment

    Measurement of blood volume by CO rebreathing

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2023
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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