NCT00378469

Brief Summary

The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

September 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2006

Completed
Last Updated

July 12, 2007

Status Verified

May 1, 2007

First QC Date

September 19, 2006

Last Update Submit

July 11, 2007

Conditions

Iron OverloadIron Deficiency

Keywords

HepcidinHemojuvelinIronHealthy volunteers

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of urinary hepcidin

  • Pharmacokinetics of blood hemojuvelin

Secondary Outcomes (1)

  • Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin

Interventions

45 minute exercise on ergocycleBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Male individuals aged between 18 and 40 years old
  • Body mass index (BMI) between 18 and 25
  • Normal at clinical examination
  • Normal biological variables
  • Written informed consent

You may not qualify if:

  • Mutation C282Y of the HFE gene
  • Iron metabolism abnormality
  • Inflammatory syndrome
  • Chronic pathology or ongoing treatment
  • Tobacco smoking, alcohol consuming more than 30g/day
  • History of transfusion or blood-giving within 3 months
  • Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service des Maladies du Foie - Hôpital de Pontchaillou

Rennes, 35033, France

RECRUITING

Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou

Rennes, 35033, France

RECRUITING

MeSH Terms

Conditions

Iron OverloadIron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pierre Brissot, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Bruno Laviolle, MD

    Rennes University Hospital

    STUDY CHAIR

Central Study Contacts

Pierre Brissot, MD

CONTACT

33-2-9928-4297pierre.brissot@univ-rennes1.fr

Fabrice Lainé, MD

CONTACT

33-2-9928-3715fabrice.laine@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 20, 2006

Study Start

September 1, 2006

Last Updated

July 12, 2007

Record last verified: 2007-05

Locations

FR(2)