Healthy VolunteersFERNORMNCT02304874
Evaluation of Body Iron Stores in Overweight Healthy Volunteers
A study testing Phlebotomy in people with Healthy Volunteers and Overweight, run by Rennes University Hospital at 1 site in France.
Trial summary
Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Overweight
- What is being tested?
- Phlebotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male,
- At least 18 years old
- BMI > 25 Kg/m2
- Serum ferritin level between 100 et 300 µg/L
- Written informed consent
Who cannot join
- Blood donations in the past two years
- Alcohol consumption more than 30 g/day
- Inflammatory syndrome (CRP > 10 mg/L)
- Inflammatory, dysimmunitary or cancerous disease
- Hepatic cytolysis
- Transferrin saturation > 45%
Show all 15Show fewer
- Person involved in another clinical trial
- Person with a measure of legal protection (guardianship)
- Person who reached the annual limit for compensation provided by biomedical research
- Hemoglobin < 13 g/dL
- Uncontrolled heart failure or coronary insufficiency
- Abnormal ECG
- Echocardiographic abnormalities contraindicating phlebotomy
- Hepatic, renal or respiratory insufficiency
- Superficial venous network insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition. The purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy.
Read the detailed description
Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition.
DIOS is the leading cause of hyperferritinemia and mainly affects men between 45 and 60 years. It is characterized by unexplained hyperferritinemia associated to metabolic disorders (including overweight) and iron overload, objectified by MRI or liver biopsy.
Some authors suggest that hyperferritinemia associated to metabolic disorders is the expression of an inflammatory syndrome caused by insulin resistance and steatohepatitis, and not the manifestation of real iron overload.
The debate surrounding iron overload in DIOS is related to the limits of the current analysis methods (phlebotomy, liver iron concentration, MRI). At present, phlebotomy is the standard method used to determine body iron stores.
Using this method, the purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy included in another ongoing clinical trial (SAIGNEES - ClinicalTrials.gov Identifier: NCT01045525).
- Conditions
- Healthy Volunteers, Overweight
- Being tested
- Phlebotomy
- Keywords
- Ferritins, Iron Overload, Metabolic Syndrome, Venesection therapy, Volunteers
- Medical subject headings
- Overweight, Iron Overload, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyOther
| Study group | Role | What they receive |
|---|---|---|
| Phlebotomy | Other | Phlebotomies will be performed every 14 days at the Clinical Investigation Unit (CIU) until the value of ferritin level is below 50 µg/mL and/or the value of hemoglobin level is below 12 g/dL. Receives: Other: Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of mobilized iron (AMI) in grams collected by phlebotomies to have a ferritin level < 50 µg/L
Phlebotomies will be performed every 14 days at the Clinical Investigation Unit, until ferritin level is below 50 µg/mL and/or hemoglobin is below 12 g/dL.
Measured: Every 14 days, up to 3 months
Secondary outcomes (2)
Serum hepcidin level variation during the phlebotomy
Measured: Every 14 days, up to 3 months
Serum soluble transferrin receptor variation during the phlebotomy
Measured: Every 14 days, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJul 2011
- Primary completionJun 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Laviolle, MD, PhD, Study chair, Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de PontchaillouCaroline Jezequel, MD, Principal investigator, Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304874
- Sponsor's protocol ID
- LOC/11-03
- Acronym
- FERNORM
- Status last verified
- May 2023
- First submitted
- 24 Nov 2014
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Jezequel C, Laine F, Laviolle B, Kiani A, Bardou-Jacquet E, Deugnier Y. Both hepatic and body iron stores are increased in dysmetabolic iron overload syndrome. A case-control study. PLoS One. 2015 Jun 1;10(6):e0128530. doi: 10.1371/journal.pone.0128530. eCollection 2015.
PubMed 26030828
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Body Iron Stores in Overweight Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02304874
- Acronym / sponsor ID
- FERNORM / LOC/11-03
- Conditions
- Healthy Volunteers, Overweight
- Keywords
- Ferritins, Iron Overload, Metabolic Syndrome, Venesection therapy, Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition. The purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy.
Detailed description
Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition.
DIOS is the leading cause of hyperferritinemia and mainly affects men between 45 and 60 years. It is characterized by unexplained hyperferritinemia associated to metabolic disorders (including overweight) and iron overload, objectified by MRI or liver biopsy.
Some authors suggest that hyperferritinemia associated to metabolic disorders is the expression of an inflammatory syndrome caused by insulin resistance and steatohepatitis, and not the manifestation of real iron overload.
The debate surrounding iron overload in DIOS is related to the limits of the current analysis methods (phlebotomy, liver iron concentration, MRI). At present, phlebotomy is the standard method used to determine body iron stores.
Using this method, the purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy included in another ongoing clinical trial (SAIGNEES - ClinicalTrials.gov Identifier: NCT01045525).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phlebotomy | Other | Other: PhlebotomyPhlebotomies will be performed every 14 days at the Clinical Investigation Unit (CIU) until the value of ferritin level is below 50 µg/mL and/or the value of hemoglobin level is below 12 g/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male,
- At least 18 years old
- BMI > 25 Kg/m2
- Serum ferritin level between 100 et 300 µg/L
- Written informed consent
Key exclusion criteria (15 listed)
- Blood donations in the past two years
- Alcohol consumption more than 30 g/day
- Inflammatory syndrome (CRP > 10 mg/L)
- Inflammatory, dysimmunitary or cancerous disease
- Hepatic cytolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phlebotomy | Other | Phlebotomy |
Primary outcome
Amount of mobilized iron (AMI) in grams collected by phlebotomies to have a ferritin level < 50 µg/L
Time frame: Every 14 days, up to 3 months
Phlebotomies will be performed every 14 days at the Clinical Investigation Unit, until ferritin level is below 50 µg/mL and/or hemoglobin is below 12 g/dL.
2 secondary outcomes
Serum hepcidin level variation during the phlebotomy
Time frame: Every 14 days, up to 3 months
Serum soluble transferrin receptor variation during the phlebotomy
Time frame: Every 14 days, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 26030828Jezequel C, Laine F, Laviolle B, Kiani A, Bardou-Jacquet E, Deugnier Y. Both hepatic and body iron stores are increased in dysmetabolic iron overload syndrome. A case-control study. PLoS One. 2015 Jun 1;10(6):e0128530. doi: 10.1371/journal.pone.0128530. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Laviolle, MD, PhD study chair
Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou
Caroline Jezequel, MD principal investigator
Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phlebotomy in people with Healthy Volunteers and Overweight, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of mobilized iron (AMI) in grams collected by phlebotomies to have a ferritin level < 50 µg/L (time frame: Every 14 days, up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02304874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.