NAFLD - Non Alcoholic Fatty Liver DiseaseBAFLANCT01307254
Association Between Non-alcoholic Fatty Liver Disease and Iron Status
An observational study of NAFLD - Non Alcoholic Fatty Liver Disease, run by Ornit Cohen at 1 site in Israel.
Trial summary
The investigators hypothesize that low iron storages protects from and down-grades non-alcoholic fatty liver disease. The aim of the study is to show the association between the severity of Non-alcoholic fatty liver disease to low iron status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD - Non Alcoholic Fatty Liver Disease
- What is being tested?
- blood analysis
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jul 2013
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that will pass a CT scan at our institution. The scan must include the abdomen, with or without any contrast material.
Who may be able to join
- age>18
- BMI>25
Who cannot join
- pregnancy
- unable to sign an informed consent (legally)
- known solid/hematological malignancy
- hemoglobinopathy or myelodysplastic disease (not including G6PD deficiency)
- active or carrier of viral hepatitis
- treated a drug the cause fatty liver (eg. amiodarone, tetracyclin, HAART, steroid treatment > 3 months)
Show all 11Show fewer
- consumption of > 120g ethanol per week
- primary liver disease (eg. glycogen storage disease)
- CRP>20
- acute intoxication
- surgery in previous 7 days
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Barzilai medical center
Ashkelon, 78278
Albert Grinshpun, 972-54-5615563, albert.grinshpun@mail.huji.ac.il
Zamir Doron, Prof
About this study
Official title: (BAFLA- Barzilai Fatty Liver and Iron Metabolism Study)
The investigators hypothesize that low iron storages protects from and down-grades non-alcoholic fatty liver disease.
The aim of the study is to show the association between the severity of Non-alcoholic fatty liver disease to low iron status.
Read the detailed description
Patients that will pass a CT scan that includes the abdomen will be asked to participate at our study. These patients will be divided into two groups - with and w/o fatty liver. The severity of fatty liver will be determined using the CT scan (as well as other parameters, such as the size of subcutaneous fat layer). Within 72 hours from the scan, a venous blood test will be taken from the enrolled patients (together with a BMI calculation and a blood pressure measurements). In the blood test we will examine liver functions, iron status etc.
This is a preliminary study that will aid in planning future strategies to treat or even prevent fatty liver (one of the epidemics of our century).
- Being tested
- blood analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood analysisProcedure or surgery
A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)
| Study group | Role | What they receive |
|---|---|---|
| Non alcoholic fatty liver disease | Not described Receives: Procedure: blood analysis | |
| control | Not described Receives: Procedure: blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
grade of fatty liver disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD - Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ornit Cohen
- Sponsor type
- University, hospital or other
- Collaborators
- Prof Doron Zamir
- Responsible party
- Sponsor-investigator, Ornit Cohen, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307254
- Sponsor's protocol ID
- BAFLA
- Acronym
- BAFLA
- Status last verified
- Sep 2012
- First submitted
- 5 Jan 2011
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (BAFLA- Barzilai Fatty Liver and Iron Metabolism Study)
- ClinicalTrials.gov ID
- NCT01307254
- Acronym / sponsor ID
- BAFLA / BAFLA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ornit CohenUniversity, hospital or other
- Collaborators
- Prof Doron Zamir
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 2 Mar 2011 (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.
The investigators hypothesize that low iron storages protects from and down-grades non-alcoholic fatty liver disease.
The aim of the study is to show the association between the severity of Non-alcoholic fatty liver disease to low iron status.
Detailed description
Patients that will pass a CT scan that includes the abdomen will be asked to participate at our study. These patients will be divided into two groups - with and w/o fatty liver. The severity of fatty liver will be determined using the CT scan (as well as other parameters, such as the size of subcutaneous fat layer). Within 72 hours from the scan, a venous blood test will be taken from the enrolled patients (together with a BMI calculation and a blood pressure measurements). In the blood test we will examine liver functions, iron status etc.
This is a preliminary study that will aid in planning future strategies to treat or even prevent fatty liver (one of the epidemics of our century).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non alcoholic fatty liver disease | – | Procedure: blood analysis |
| control | – | Procedure: blood analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that will pass a CT scan at our institution. The scan must include the abdomen, with or without any contrast material.
Key inclusion criteria (2 listed)
- age>18
- BMI>25
Key exclusion criteria (11 listed)
- pregnancy
- unable to sign an informed consent (legally)
- known solid/hematological malignancy
- hemoglobinopathy or myelodysplastic disease (not including G6PD deficiency)
- active or carrier of viral hepatitis
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 |
|---|---|---|
| blood analysisA single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate) | Procedure or surgery | Non alcoholic fatty liver disease, control |
Primary outcome
grade of fatty liver disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD - Non Alcoholic Fatty Liver Disease, run by Ornit Cohen at 1 site in Israel.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Sep 2012. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Grinshpun (972-54-5615563, albert.grinshpun@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grade of fatty liver disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2012.