Tracing Changed Production of Red Blood Cells

Erythrocytosis Clinical Trial

Official title:

Tracing Changed Production of Red Blood Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05833477
• Other study ID #: H-20064997
• Status: Completed
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: April 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erythrocytosis
• Erythropoiesis Abnormal
• Polycythemia

Intervention

Drug:
• Recombinant human erythropoietin
Recombinant human erythropoietin treatment three times per week for three weeks

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Continous blood glucose levels	Continuous blood glucose level throughout the study	In the period from two weeks before treatment to three weeks after treatment
Secondary	Changes in CD71 cryopreserved	CD71 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Secondary	Changes in CD35 cryopreserved	CD35 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Secondary	Changes in CD47 cryopreserved	CD47 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Secondary	Changes in CD55 cryopreserved	CD55 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Secondary	Changes in CD59 cryopreserved	CD59 expression on red blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Secondary	Changes in RNA cryopreserved	RNA expression inred blood cells before and after cryopreservation	Cryopreserved cells are measured 6 months after sample collection
Secondary	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
Secondary	Changes in Ferritin	Quantification of plasma ferritin concentration	In the period from two weeks before treatment to three weeks after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in ALAS 2	Quantification of ALAS 2 in dried blood spots stored at room temperature, -20C and -80C	Up to 5 years
Secondary	Changes in CA1	Quantification of CA1 in dried blood spots	Up to 5 years
Secondary	Changes in SLC4a1	Quantification of SLC4a1 in dried blood spots	Up to 5 years
Secondary	Changes in CD71 in dried blood spots	Quantification of CD71 in dried blood spots	Up to 5 years
Secondary	Changes in FECH	Quantification of FECH in dried blood spots	Up to 5 years
Secondary	Changes in Band 3	Quantification of Band 3 in dried blood spots	Up to 5 years
Secondary	Changes in blood volume	Measurement of blood volume by CO rebreathing	Within 14 days before treatment and within 14 days after treatment