NCT00687518

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

May 30, 2008

Status Verified

May 1, 2008

Enrollment Period

8 months

First QC Date

May 27, 2008

Last Update Submit

May 29, 2008

Conditions

Iron Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • serum hepcidin levels

    over 24 hours

Secondary Outcomes (2)

  • urinary hepcidin levels

    over 24 hours

  • serum iron and ferritin levels

    over 24 hours

Study Arms (2)

1

EXPERIMENTAL

erythropoietin

Drug: Erythropoietin

2

PLACEBO COMPARATOR

Saline serum

Drug: Placebo

Interventions

ErythropoietinDRUG

Intravenous injection of 50 U/kg of erythropoietin

Also known as: Neorecormon®
1
PlaceboDRUG

Intravenous injection of equivalent volume of saline serum

Also known as: NaCl 0,9%
2

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers
  • male aged 18 - 30
  • normal routine laboratory values
  • normal ECG
  • normal iron status

You may not qualify if:

  • C282Y mutation of the HFE gene
  • alcohol or tobacco consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou

Rennes, 35033, France

RECRUITING

Related Publications (1)

  • Laine F, Laviolle B, Ropert M, Bouguen G, Morcet J, Hamon C, Massart C, Westermann M, Deugnier Y, Loreal O. Early effects of erythropoietin on serum hepcidin and serum iron bioavailability in healthy volunteers. Eur J Appl Physiol. 2012 Apr;112(4):1391-7. doi: 10.1007/s00421-011-2097-7. Epub 2011 Aug 5.

    PMID: 21818622DERIVED

MeSH Terms

Conditions

Iron Metabolism Disorders

Interventions

Erythropoietinepoetin beta

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Fabrice LAINE, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Bruno LAVIOLLE, MD

    RennesUniversity Hospital

    STUDY CHAIR

Central Study Contacts

Fabrice LAINE, MD

CONTACT

33-2-9928-9199fabrice.laine@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

March 1, 2008

Primary Completion

November 1, 2008

Study Completion

February 1, 2009

Last Updated

May 30, 2008

Record last verified: 2008-05

Locations

FR(1)