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ACTIVE NOT RECRUITING
NCT04227665
NA

Identifying Biological Markers for Altitude Exposure and Use of Recombinant Human Erythropoietin (rHuEPO)

Sponsor: University of Copenhagen

View on ClinicalTrials.gov

Summary

The project represents a well powered study of the human response to altitude exposure combined with rHuEPO treatment. A total of 20 male and 20 female non-competing athletes will participate. The participants will be exposed to a period of hypobaric hypoxia at 2.320 m for four weeks and a sea-level intervention period of four weeks. The participants will be blinded and randomly allocated to intra venous injection with 20 IU per kg body weight of recombinant human erythropoietin or placebo every second day for the initial three weeks of each intervention. Included subjects will be runners due to the good possibility of recruitment and conduction of training at altitude. Samples are collected weekly for four weeks prior to each intervention period, during the four week intervention and four weeks after. This approach yields a highly valuable biobank for identification of markers sensitive to initiation of rHuEPO injections as well as termination of injections.

Official title: Identification of Biological Markers for Hypoxic Exposure and Use of Recombinant Human Erythropoietin

Key Details

Gender

All

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2018-03-01

Completion Date

2025-05-30

Last Updated

2024-12-09

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Sea level

Sea level exposure / sea level exposure combined with microdoses of rHuEPO

OTHER

Altitude

Altitude exposure / altitude exposure Iron metabolism

Locations (1)

University of Copenhagen

Copenhagen, Copenhagen Ø, Denmark