Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis (NCT01810965) | Clinical Trial Compass
CompletedNot Applicable
Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis
France6 participantsStarted 2013-06-03
Plain-language 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 (5/1000 in Brittany, France).
For the half of these predisposed subjects, the phenotypic expression of the disease needs a treatment. This treatment is based upon repeated bloodletting which is generally considered as simple, safe and effective.
Nevertheless, it is still questioned as regard its physiopathological justification and its clinical implications. Indeed, bloodletting could cause an increase of non-transferrin bound iron (NTBI) particularly for its reactive form called labile plasma iron (LPI) This adverse physiopathological effect could have clinical consequences and could be linked with articular consequences which can be aggravated by the treatment.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximal variation (delta maximum) of NTBI during the 5 days following a bloodletting