Tracing Changed Production of Red Blood Cells

• Sponsor: University of Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT05833477
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Erythrocytosis; Erythropoiesis Abnormal	Drug: Recombinant human erythropoietin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Tracing Changed Production of Red Blood Cells
• Actual Study Start Date: Oct 28, 2022
• Actual Primary Completion Date: Dec 16, 2022
• Actual Study Completion Date: Dec 16, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in CD71 expression [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 [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 [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 [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 [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 [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 [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 Outcome Measures

1. Changes in HbA1c [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 [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 [Cryopreserved cells are measured 6 months after sample collection]

   CD71 expression on red blood cells before and after cryopreservation

4. Changes in CD35 cryopreserved [Cryopreserved cells are measured 6 months after sample collection]

   CD35 expression on red blood cells before and after cryopreservation

5. Changes in CD47 cryopreserved [Cryopreserved cells are measured 6 months after sample collection]

   CD47 expression on red blood cells before and after cryopreservation

6. Changes in CD55 cryopreserved [Cryopreserved cells are measured 6 months after sample collection]

   CD55 expression on red blood cells before and after cryopreservation

7. Changes in CD59 cryopreserved [Cryopreserved cells are measured 6 months after sample collection]

   CD59 expression on red blood cells before and after cryopreservation

8. Changes in RNA cryopreserved [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 [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 [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 [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 [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 [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 [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 [Up to 5 years]

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

16. Changes in CA1 [Up to 5 years]

    Quantification of CA1 in dried blood spots

17. Changes in SLC4a1 [Up to 5 years]

    Quantification of SLC4a1 in dried blood spots

18. Changes in CD71 in dried blood spots [Up to 5 years]

    Quantification of CD71 in dried blood spots

19. Changes in FECH [Up to 5 years]

    Quantification of FECH in dried blood spots

20. Changes in Band 3 [Up to 5 years]

    Quantification of Band 3 in dried blood spots

21. Changes in blood volume [Within 14 days before treatment and within 14 days after treatment]

    Measurement of blood volume by CO rebreathing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Copenhagen
• ClinicalTrials.gov Identifier: NCT05833477
• Other Study ID Numbers: H-20064997
• First Posted: Apr 27, 2023
• Last Update Posted: Apr 27, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Polycythemia; Epoetin Alfa

Study Results

No Results Posted as of Apr 27, 2023