Status:
COMPLETED
Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis
Lead Sponsor:
Rennes University Hospital
Conditions:
Hemochromatosis Type 1
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Hemochromatosis type 1 is one of the most frequent genetic disease since the genetic predisposition (homozygosity for the C282Y mutation of the HFE gene) is encountered in about 3/1000 white subjects ...
Detailed Description
Hemochromatosis type 1 is one of the most frequent genetic disease since the genetic predisposition (homozygosity for the C282Y mutation of the HFE gene) is encountered in about 3/1000 white subjects ...
Eligibility Criteria
Inclusion
- Men
- Age 18 years or older
- Homozygosity for the C282Y mutation of the HFE gene
- With an indication of treatment by bloodletting (in accordance with the French HAS guidelines)
- Ferritinemia ≥ 500µg/L
- Transferrin saturation ≥ 75%
- Never treated by bloodletting
- Written informed consent
Exclusion
- Contraindication to bloodletting
- Chronic inflammatory or dysmetabolic or neoplastic disease
- Major cardiovascular disease
- Excessive consumption of alcohol (≥ 3gr/day)
- Treatment by iron chelators, C or E vitamins
- Stay in altitude\> 1500m in the month preceding the period Day 1
- Patients under guardianship
- Blood donation in the 3 past months
- Night / shift workers
Key Trial Info
Start Date :
June 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01810965
Start Date
June 3 2013
End Date
April 19 2019
Last Update
June 11 2021
Active Locations (1)
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1
CHU Pontchaillou
Rennes, France, 35000