Status:
UNKNOWN
Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans
Lead Sponsor:
University of Zurich
Conditions:
Healthy
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
PHASE2
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 ha...
Eligibility Criteria
Inclusion
- 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;
Exclusion
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01889056
Start Date
February 1 2013
End Date
December 1 2013
Last Update
June 28 2013
Active Locations (1)
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1
University Hospital Zurich, Medical intensive care unit
Zurich, Canton of Zurich, Switzerland, 8091