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Tracing Changed Production of Red Blood Cells

Primary Purpose

Erythrocytosis, Erythropoiesis Abnormal

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Recombinant human erythropoietin
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Erythrocytosis

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Nutrition, Exercise and Sports

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Recombinant human erythropoietin treatment three times per week for three weeks

Outcomes

Primary Outcome Measures

Changes in CD71 expression
Treatment induced changes in CD71 expression on red blood cells
Changes in CD35 expression
Treatment induced changes in CD35 expression on red blood cells
Changes in CD47 expression
Treatment induced changes in CD47 expression on red blood cells
Changes in CD55 expression
Treatment induced changes in CD55 expression on red blood cells
Changes in CD59 expression
Treatment induced changes in CD59 expression on red blood cells
Changes in RNA expression
Treatment induced changes in RNA expression in red blood cells
Changes in Mean Cell Volume
Treatment induced changes in Mean Cell Volume distribution of red blood cells

Secondary Outcome Measures

Changes in HbA1c
Treatment induced changes in HbA1c content of red blood cells
Continous blood glucose levels
Continuous blood glucose level throughout the study
Changes in CD71 cryopreserved
CD71 expression on red blood cells before and after cryopreservation
Changes in CD35 cryopreserved
CD35 expression on red blood cells before and after cryopreservation
Changes in CD47 cryopreserved
CD47 expression on red blood cells before and after cryopreservation
Changes in CD55 cryopreserved
CD55 expression on red blood cells before and after cryopreservation
Changes in CD59 cryopreserved
CD59 expression on red blood cells before and after cryopreservation
Changes in RNA cryopreserved
RNA expression inred blood cells before and after cryopreservation
Changes in Mean Cell Volume cryopreserved
Mean Cell Volume distribution of red blood cells before and after cryopreservation
Changes in Ferritin
Quantification of plasma ferritin concentration
Changes in Complete Blood Count on Advia
Complete Blood Count analysis on the Advia 2120i instrument
Changes in Complete Blood Count on Sysmex
Complete Blood Count analysis on the Sysmex XN-450 instrument
Changes in Complete Blood Count on Advia - cryopreserved
Complete Blood Count analysis on the Advia 2120i instrument before and after cryopreservation
Changes in Complete Blood Count on Sysmex - cryopreserved
Complete Blood Count analysis on the Sysmex XN-450 instrument before and after cryopreservation
Changes in ALAS 2
Quantification of ALAS 2 in dried blood spots stored at room temperature, -20C and -80C
Changes in CA1
Quantification of CA1 in dried blood spots
Changes in SLC4a1
Quantification of SLC4a1 in dried blood spots
Changes in CD71 in dried blood spots
Quantification of CD71 in dried blood spots
Changes in FECH
Quantification of FECH in dried blood spots
Changes in Band 3
Quantification of Band 3 in dried blood spots
Changes in blood volume
Measurement of blood volume by CO rebreathing

Full Information

First Posted
September 22, 2022
Last Updated
April 25, 2023
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05833477
Brief Title
Tracing Changed Production of Red Blood Cells
Official Title
Tracing Changed Production of Red Blood Cells
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Copenhagen

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythrocytosis, Erythropoiesis Abnormal

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Bejder, Ph.D.
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Tracing Changed Production of Red Blood Cells

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