Clinical trial NCT01889056: Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Erythropoietin
Cognition
Exercise
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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;

Primary outcomes:
measure: Cognitive Function
timeFrame: 1 year
Secondary outcomes:
measure: Exercise Capacity
timeFrame: 1 year
Other outcomes:
measure: Subjective Well-Being
timeFrame: 1 year
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Medical intensive care unit
state: ZH
Study officials:
affiliation: University Hospital Zurich, Medical intensive care unit
name: Marco Maggiorini, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: