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

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ClinicalTrials.gov Identifier: NCT03250572
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Shereen Abou Bakr Saleh, Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment
Non-Alcoholic Fatty Liver Disease Diagnostic Test: serum ferritin

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among Non-alcoholic Fatty Liver Disease Patients
Actual Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016


Group/Cohort Intervention/treatment
control group Diagnostic Test: serum ferritin
serum samples and ferritin ELISA test

NAFLD patients without hepatic fibrosis Diagnostic Test: serum ferritin
serum samples and ferritin ELISA test

NAFLD patients with hepatic fibrosis Diagnostic Test: serum ferritin
serum samples and ferritin ELISA test




Primary Outcome Measures :
  1. Serum ferritin in patients with hepatic fibrosis on top of NAFLD [ Time Frame: 1 year ]
    measurement of serum ferritin in patients with hepatic fibrosis on top NAFLD in comparison with normal control and simple steatosis



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Group I: included 30 healthy subjects as control. Group II: included 31 patients with NAFLD without liver fibrosis. Group III: included 52 patients with hepatic fibrosis on top of NAFLD.
Criteria

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.
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Responsible Party: Shereen Abou Bakr Saleh, Asisstant Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03250572    
Other Study ID Numbers: 9875
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases