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

NCT04227665 | Active Not Recruiting DMC

• 1 other identifier: H-17036662
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Identification of metabolites in urine for rHuEPO and altitude exposure

  Urine is analyzed by metabolomics and the metabolites for rHuEPO and altitude are verified using an exploratory design. More specifically, the aim is to identify the resulting metabolites from altitude exposure and treatment with rHuEPO as these are not yet known In this WADA-supported research project, the aim is to identify high sensitivity biomarkers for altitude exposure through a metabolomics methods, as 'omics' methods have previously shown promising results in other exposure contexts. However, being the first of its kind in antidoping the resulting metabolites from rHuEPO misuse and altitude have not yet been identified. Thus, an exact description of these is not possible

  5 years

• Identification of human metabolites in serum for rHuEPO and altitude exposure

  Human serum is analyzed by metabolomics and the metabolites for rHuEPO and altitude are verified using an exploratory design.

  5 years

Secondary Outcomes (10)

• Reticulocyte percentage

  Up to 24 weeks

• Hemoglobin concentration

  Up to 24 weeks

• OFF-score

  Up to 24 weeks

• Maximal oxygen uptake (VO2max)

  Up to 24 weeks

• Iron metabolism

  Up to 24 weeks

Study Arms (2)

Sea level

EXPERIMENTAL

Sea level training camp

Other: Sea level

Altitude

EXPERIMENTAL

Altitude training camp

Other: Altitude

Interventions

Sea level OTHER

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

Sea level

Altitude OTHER

Altitude exposure / altitude exposure Iron metabolism

Altitude

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male: VO2max \> 48 ml/min/kg bodyweight and 5km run \< 22 min, Female: VO2max \> 43ml/min/kg bodyweight and 5km run \< 25 min A minimum of 2 years injury running training

You may not qualify if:

• Age, insufficient fitness or injury

Sponsors & Collaborators

• University of Copenhagen: lead
• World Anti-Doping Agency: collaborator
• German Sport University, Cologne: collaborator
• Universidad de Granada: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, Copenhagen Ø, 2200, Denmark

Location

Related Publications (1)

• Arrebola-Moreno AL, Casuso RA, Bejder J, Bonne TC, Breenfeldt Andersen A, Aragon-Vela J, Nordsborg NB, Huertas JR. Does Hypoxia and Stress Erythropoiesis Compromise Cardiac Function in Healthy Adults? A Randomized Trial. Sports Med Open. 2022 Nov 5;8(1):137. doi: 10.1186/s40798-022-00531-x.

  PMID: 36334130 DERIVED

MeSH Terms

Interventions

Sea Level Rise; Altitude

Intervention Hierarchy (Ancestors)

Oceans and Seas; Geological Phenomena; Physical Phenomena; Climate Change; Climatic Processes; Ecological and Environmental Phenomena; Biological Phenomena; Water Movements; Environment; Environment and Public Health

Study Officials

• Jacob Bejder, Msc

  Universuty of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Explorative design

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: January 14, 2020
• Study Start: March 1, 2018
• Primary Completion: June 26, 2019
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)