Study of the Effects of Muscular Activity on Iron Metabolism

Iron Deficiency Clinical Trial

Official title:

Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00378469
• Other study ID #: DGS 2006/0415
• Secondary ID: LOC/05-07CIC0203
• Status: Recruiting
• Phase: N/A
• First received: September 19, 2006
• Last updated: July 11, 2007
• Start date: September 2006

Study information

• Verified date: May 2007
• Source: Rennes University Hospital
• Contact: Pierre Brissot, MD
• Phone: 33-2-9928-4297
• Email: pierre.brissot[@]univ-rennes1.fr
• Is FDA regulated: No
• Health authority: France: DGS - Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency
• Iron Overload

Intervention

Behavioral:
• 45 minute exercise on ergocycle

Locations

Country	Name	City	State
France	Service des Maladies du Foie - Hôpital de Pontchaillou	Rennes
France	Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of urinary hepcidin
Primary	Pharmacokinetics of blood hemojuvelin
Secondary	Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin