Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study of the Effects of Muscular Activity on Iron Metabolism

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Rennes University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00378469
First received: September 19, 2006
Last updated: July 11, 2007
Last verified: May 2007
  Purpose
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.

Condition Intervention
Iron Overload
Iron Deficiency
Behavioral: 45 minute exercise on ergocycle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Pharmacokinetics of urinary hepcidin
  • Pharmacokinetics of blood hemojuvelin

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

Estimated Enrollment: 14
Study Start Date: September 2006
Detailed Description:

Hemojuvelin has been described as interfering with hepcidin, a key regulator of iron homeostasis. Hemojuvelin is mainly produced by muscle, and the relationship between exercise and iron metabolism can be questioned about.

The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will be investigated at two periods according to a cross-over design after:

  1. 45 minutes of exercise on the ergocycle; and
  2. no physical exercise.

Urine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378469

Locations
France
Service des Maladies du Foie - Hôpital de Pontchaillou
Rennes, France, 35033
Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Pierre Brissot, MD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00378469     History of Changes
Other Study ID Numbers: DGS 2006/0415  LOC/05-07  CIC0203/061 
Study First Received: September 19, 2006
Last Updated: July 11, 2007
Health Authority: France: DGS - Direction Générale de la Santé

Keywords provided by Rennes University Hospital:
Hepcidin
Hemojuvelin
Iron
Healthy volunteers

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Iron Overload
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on December 02, 2016