Clinical trial NCT05833477: Tracing Changed Production of Red Blood Cells
Official title: Tracing Changed Production of Red Blood Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythrocytosis
Erythropoiesis Abnormal
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Changes in CD71 expression
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in CD35 expression
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in CD47 expression
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in CD55 expression
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in CD59 expression
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in RNA expression
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in Mean Cell Volume
timeFrame: In the period from two weeks before treatment to three weeks after treatment
Secondary outcomes:
measure: Changes in HbA1c
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Continous blood glucose levels
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in CD71 cryopreserved
timeFrame: Cryopreserved cells are measured 6 months after sample collection
measure: Changes in CD35 cryopreserved
timeFrame: Cryopreserved cells are measured 6 months after sample collection
measure: Changes in CD47 cryopreserved
timeFrame: Cryopreserved cells are measured 6 months after sample collection
measure: Changes in CD55 cryopreserved
timeFrame: Cryopreserved cells are measured 6 months after sample collection
measure: Changes in CD59 cryopreserved
timeFrame: Cryopreserved cells are measured 6 months after sample collection
measure: Changes in RNA cryopreserved
timeFrame: Cryopreserved cells are measured 6 months after sample collection
measure: Changes in Mean Cell Volume cryopreserved
timeFrame: Cryopreserved cells are measured 6 months after sample collection
measure: Changes in Ferritin
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in Complete Blood Count on Advia
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in Complete Blood Count on Sysmex
timeFrame: In the period from two weeks before treatment to three weeks after treatment
measure: Changes in Complete Blood Count on Advia - cryopreserved
timeFrame: Cryopreserved cells are measured 6 months after sample collection
measure: Changes in Complete Blood Count on Sysmex - cryopreserved
timeFrame: Cryopreserved cells are measured 6 months after sample collection
measure: Changes in ALAS 2
timeFrame: Up to 5 years
measure: Changes in CA1
timeFrame: Up to 5 years
measure: Changes in SLC4a1
timeFrame: Up to 5 years
measure: Changes in CD71 in dried blood spots
timeFrame: Up to 5 years
measure: Changes in FECH
timeFrame: Up to 5 years
measure: Changes in Band 3
timeFrame: Up to 5 years
measure: Changes in blood volume
timeFrame: Within 14 days before treatment and within 14 days after treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
Study officials:
affiliation: University of Copenhagen
name: Jacob Bejder, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: