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Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis (SAIFER)

Primary Purpose

Hemochromatosis Type 1

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
First evaluation phase : no intervention / Second evaluation phase: bloodletting of 7 ml/kg (with a maximum of 500ml)
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemochromatosis Type 1 focused on measuring Hemochromatosis type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Pontchaillou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort

Arm Description

Outcomes

Primary Outcome Measures

Maximal variation (delta maximum) of NTBI during the 5 days following a bloodletting

Secondary Outcome Measures

Kinetic of NTBI plasmatic concentration during the 5 days following a bloodletting
Maximal variation (delta maximum) of LPI during the 5 days following a bloodletting
Maximal variation (delta maximum) of hepcidin during the 5 days following a bloodletting
Kinetic of LPI plasmatic concentration during the 5 days following a bloodletting
Kinetic of hepcidin plasmatic concentration during the 5 days following a bloodletting
CRP
Hemoglobin
Soluble transferrin receptor
EPO
Circadian kinetic of NTBI plasmatic concentration when no bloodletting is performed
Circadian kinetic of API plasmatic concentration when no bloodletting is performed
Circadian kinetic of hepcidine plasmatic concentration when no bloodletting is performed
Maximal variation (delta maximum) of transferrin saturation during the 5 days following a bloodletting
Kinetic of transferrin saturation during the 5 days following a bloodletting

Full Information

First Posted
March 12, 2013
Last Updated
June 8, 2021
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01810965
Brief Title
Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis
Acronym
SAIFER
Official Title
Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis: Pathophysiological and Clinical Implications. Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 3, 2013 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
April 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 (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.
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 (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. The primary objective is to explore the effect of bloodletting upon plasmatic concentrations of NTBI. The secondary objectives are to: explore the impact of bloodletting upon different parameters of iron metabolism and in particular LPI, hepcidinemia and markers of erythropoiesis ; explore basal and nycthemeral characteristics of new parameters of iron metabolism (hepcidin, NTBI, LPI) in hemochromatosis patients. The demonstration of an adverse effect of bloodletting upon iron metabolism would allow for a therapeutic innovation based upon an association of bloodletting and oral chelation during the induction treatment of type 1 hemochromatosis and, more generally in hepcidino deficient forms of hemochromatosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemochromatosis Type 1
Keywords
Hemochromatosis type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
First evaluation phase : no intervention / Second evaluation phase: bloodletting of 7 ml/kg (with a maximum of 500ml)
Primary Outcome Measure Information:
Title
Maximal variation (delta maximum) of NTBI during the 5 days following a bloodletting
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Kinetic of NTBI plasmatic concentration during the 5 days following a bloodletting
Time Frame
Day 5
Title
Maximal variation (delta maximum) of LPI during the 5 days following a bloodletting
Time Frame
Day 5
Title
Maximal variation (delta maximum) of hepcidin during the 5 days following a bloodletting
Time Frame
Day 5
Title
Kinetic of LPI plasmatic concentration during the 5 days following a bloodletting
Time Frame
Day 5
Title
Kinetic of hepcidin plasmatic concentration during the 5 days following a bloodletting
Time Frame
Day 5
Title
CRP
Time Frame
Day 9, day 10, day 11 and day 12
Title
Hemoglobin
Time Frame
Day 9, day 10, day 11 and day 12
Title
Soluble transferrin receptor
Time Frame
Day 9, day 10, day 11 and day 12
Title
EPO
Time Frame
Day 9, day 10, day 11 and day 12
Title
Circadian kinetic of NTBI plasmatic concentration when no bloodletting is performed
Time Frame
Day 1
Title
Circadian kinetic of API plasmatic concentration when no bloodletting is performed
Time Frame
Day 1
Title
Circadian kinetic of hepcidine plasmatic concentration when no bloodletting is performed
Time Frame
Day 1
Title
Maximal variation (delta maximum) of transferrin saturation during the 5 days following a bloodletting
Time Frame
Day 5
Title
Kinetic of transferrin saturation during the 5 days following a bloodletting
Time Frame
Day 5

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Ropert-Bouchet, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Laviolle, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

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Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis

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