Tracing Changed Production of Red Blood Cells

NCT ID: NCT05833477

Last Updated: 2023-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-28

Study Completion Date

2022-12-16

Brief Summary

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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.

Detailed Description

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Conditions

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Erythrocytosis Erythropoiesis Abnormal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment group

Recombinant human erythropoietin treatment three times per week for three weeks

Group Type EXPERIMENTAL

Recombinant human erythropoietin

Intervention Type DRUG

Recombinant human erythropoietin treatment three times per week for three weeks

Interventions

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Recombinant human erythropoietin

Recombinant human erythropoietin treatment three times per week for three weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Bejder, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Department of Nutrition, Exercise and Sports

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-20064997

Identifier Type: -

Identifier Source: org_study_id

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