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

NCT04227665 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

OTHER

Sea level

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

OTHER

Altitude

Altitude exposure / altitude exposure Iron metabolism

Sponsors & Collaborators

  • World Anti-Doping Agency

    collaborator OTHER

  • German Sport University, Cologne

    collaborator OTHER

  • Universidad de Granada

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Jacob Bejder, Msc · Universuty of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-06-26
Completion
2027-05-30

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04227665 on ClinicalTrials.gov