NCT01307254

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

January 5, 2011

Last Update Submit

September 19, 2012

Conditions

NAFLD - Non Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • grade of fatty liver disease

    1 year

Study Arms (2)

Non alcoholic fatty liver disease

Procedure: blood analysis

control

Procedure: blood analysis

Interventions

blood analysisPROCEDURE

A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)

Non alcoholic fatty liver diseasecontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients that will pass a CT scan at our institution. The scan must include the abdomen, with or without any contrast material.

You may qualify if:

  • age\>18
  • BMI\>25

You may not qualify if:

  • 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)
  • consumption of \> 120g ethanol per week
  • primary liver disease (eg. glycogen storage disease)
  • CRP\>20
  • acute intoxication
  • surgery in previous 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barzilai medical center

Ashkelon, 78278, Israel

RECRUITING

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Albert Grinshpun

CONTACT

972-54-5615563albert.grinshpun@mail.huji.ac.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
r&d unit

Study Record Dates

First Submitted

January 5, 2011

First Posted

March 2, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

July 1, 2013

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations

IL(1)