Iron Metabolism Disorders Clinical Trial
— HEPEPOOfficial title:
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
The aim of this study is to measure the variations of serum and urinary hepcidin levels following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be postulated that erythropoietin could modulate hepcidin synthesis.
| Status | Recruiting |
| Enrollment | 14 |
| Est. completion date | February 2009 |
| Est. primary completion date | November 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - healthy volunteers - male aged 18 - 30 - normal routine laboratory values - normal ECG - normal iron status Exclusion Criteria: - C282Y mutation of the HFE gene - alcohol or tobacco consumption |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | serum hepcidin levels | over 24 hours | No | |
| Secondary | urinary hepcidin levels | over 24 hours | No | |
| Secondary | serum iron and ferritin levels | over 24 hours | No |
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