NCT03250572

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

August 8, 2017

Last Update Submit

August 12, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum ferritin in patients with hepatic fibrosis on top of NAFLD

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

    1 year

Study Arms (3)

control group

Diagnostic Test: serum ferritin

NAFLD patients without hepatic fibrosis

Diagnostic Test: serum ferritin

NAFLD patients with hepatic fibrosis

Diagnostic Test: serum ferritin

Interventions

serum ferritinDIAGNOSTIC_TEST

serum samples and ferritin ELISA test

NAFLD patients with hepatic fibrosisNAFLD patients without hepatic fibrosiscontrol group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • adult patients with NAFLD with or without hepatic fibrosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 15, 2017

Study Start

June 1, 2015

Primary Completion

July 1, 2016

Study Completion

November 1, 2016

Last Updated

August 15, 2017

Record last verified: 2017-08