Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among NAFLD Patients

NCT ID: NCT03250572

Last Updated: 2017-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-11-30

Brief Summary

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This study was designed to assess the relation between serum ferritin and hepatic fibrosis in patients with NAFLD. It included 83 patients with NAFLD with or without hepatic fibrosis, in addition to 30 healthy subjects included as controls. Measurement of serum ferritin and its correlation with steatosis and fibrosis was done.

Detailed Description

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Background: many studies have found a relationship between hepatic iron, serum ferritin and NAFLD or its progress. Aim of the work: is to assess the value of serum ferritin as a non-invasive marker in prediction of hepatic fibrosis in NAFLD. Methods: This study included 113 subjects who were classified into 3 groups. Group I: included 30 healthy subjects as control with no evidence of NAFLD by liver biopsy. Group II: included 31 NAFLD patients without fibrosis proved by liver biopsy. Group III: included 52 patients with hepatic fibrosis on top of NAFLD proved by liver biopsy. Serum ferritin was determined using Ferritin ELISA kit. FIB4 was calculated and liver biopsy was done for all patients.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

serum ferritin

Intervention Type DIAGNOSTIC_TEST

serum samples and ferritin ELISA test

NAFLD patients without hepatic fibrosis

serum ferritin

Intervention Type DIAGNOSTIC_TEST

serum samples and ferritin ELISA test

NAFLD patients with hepatic fibrosis

serum ferritin

Intervention Type DIAGNOSTIC_TEST

serum samples and ferritin ELISA test

Interventions

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serum ferritin

serum samples and ferritin ELISA test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* adult patients with NAFLD with or without hepatic fibrosis

Exclusion Criteria

* Significant alcohol consumption, other causes of liver disease such as viral hepatitis, schistosomiasis, autoimmune, hereditary, drug induced, or decompensated liver cirrhosis.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Shereen Abou Bakr Saleh

Asisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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9875

Identifier Type: -

Identifier Source: org_study_id

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