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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03250572
• Collaborator: (none)
• Enrollment: 113
• Actual Duration (Months): 17.1

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Jun 1, 2015
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Serum ferritin in patients with hepatic fibrosis on top of NAFLD [1 year]

   measurement of serum ferritin in patients with hepatic fibrosis on top NAFLD in comparison with normal control and simple steatosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shereen Abou Bakr Saleh, Asisstant Professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03250572
• Other Study ID Numbers: 9875
• First Posted: Aug 15, 2017
• Last Update Posted: Aug 15, 2017
• Last Verified: Aug 1, 2017

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

Study Results

No Results Posted as of Aug 15, 2017