Iron Deficiency Clinical Trial
Official title:
Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers
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.
Status | Recruiting |
Enrollment | 14 |
Est. completion date | |
Est. primary completion date | |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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 |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
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 |
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