Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans

NCT ID: NCT01889056

Last Updated: 2013-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-12-31

Brief Summary

The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the brain, especially under hypoxic conditions. It has been shown in animal studies and human studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome the blood brain barrier. In a double blind placebo controlled crossover study we will investigate the effects of a single high dose of Epo on cognitive function and exercise capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU) and will perform a computerized cognitive test battery, a breathing test, a maximal exercise capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary outcome of the study will be the cognitive function.

• Trial with medicinal product

Conditions

Healthy

Keywords

Erythropoietin; Cognition; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Erythropoietin (Epoetin beta)

Short infusion of 60.000 IU Epoetin beta in 0.9% sodium chloride solution (250 ml)

Group Type: EXPERIMENTAL

Erythropoietin (Epoetin beta)

Intervention Type: DRUG

0.9% sodium chloride solution

Short infusion of 0.9% sodium chloride solution (250 ml)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% sodium chloride solution

Interventions

Erythropoietin (Epoetin beta)

Intervention Type: DRUG

Placebo

0.9% sodium chloride solution

Intervention Type: DRUG

Other Intervention Names

Recormon

Eligibility Criteria

Inclusion Criteria

• Healthy Subjects;
• Age between 18 to 35 years;
• Normal body weight (body mass index of >= 18.5 kg/m2 <= 24.9 kg/m2);
• Nonsmokers (>= 1 year);
• VO2max of <= 55 ml/kg/min for females and <= 60 ml/kg/min for males;

Exclusion Criteria

• Persons with abnormal Serum Ferritin levels according to gender dependent reference values of GCP-certificated laboratory;
• Persons with pre-existing genetic hemostatic disorders (Factor V Leiden mutation, Prothrombin mutation);
• Persons which are at risk of deep venous thrombosis (e.g. history of venous thromboembolic events);
• Persons with a hematocrit value of > 55%;
• Persons being exposed to prolonged (>= 5 days) high altitude (>= 2500m above Normal Null) <= 6 months prior the beginning of the study;
• Persons not willing to maintain their living conditions during the study period (e.g. preparing for a certain competition);
• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
• Pregnant or breast feeding women;
• Intention to become pregnant during the course of the study;
• Lack of safe contraception;
• Treatment with other investigational products;
• Known or suspected non-compliance, drug or alcohol abuse;
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders;
• Participation in another study with investigational drug within the 30 days preceding and during the present study;
• Enrolment of the investigator, his/her family members, employees and other dependent persons;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Maggiorini, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Medical intensive care unit

Locations

University Hospital Zurich, Medical intensive care unit

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

EPOPERF CH12

Identifier Type: -

Identifier Source: org_study_id