NCT05833477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

September 22, 2022

Last Update Submit

April 25, 2023

Conditions

ErythrocytosisErythropoiesis Abnormal

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (21)

  • Changes in HbA1c

    In the period from two weeks before treatment to three weeks after treatment

  • Continous blood glucose levels

    In the period from two weeks before treatment to three weeks after treatment

  • Changes in CD71 cryopreserved

    Cryopreserved cells are measured 6 months after sample collection

  • Changes in CD35 cryopreserved

    Cryopreserved cells are measured 6 months after sample collection

  • Changes in CD47 cryopreserved

    Cryopreserved cells are measured 6 months after sample collection

  • +16 more secondary outcomes

Study Arms (1)

Treatment group

EXPERIMENTAL

Recombinant human erythropoietin treatment three times per week for three weeks

Drug: Recombinant human erythropoietin

Interventions

Recombinant human erythropoietinDRUG

Recombinant human erythropoietin treatment three times per week for three weeks

Treatment group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men
  • years
  • physical fitness rating more than 50ml/kg/min
  • non-smokers
  • blood pressure \<130/90 mmHg
  • hemoglobin concentration 7-10.5 mM.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Polycythemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jacob Bejder, Ph.D.

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2022

First Posted

April 27, 2023

Study Start

October 28, 2022

Primary Completion

December 16, 2022

Study Completion

December 16, 2022

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)