Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children

August 19, 2014 updated by: Piotr Socha

Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children - a Randomized, Double Blind, Placebo Controlled, Multicenter Study

The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

76 children or adolescents aged 6-19 with NAFLD will be included in the study. Diagnosis of NAFLD is set by increased alanine transaminase and features of liver steatosis on ultrasound. Patients will be randomized to receive either fish oil (EPA/DHA, 400-1200mg) or placebo (sunflower oil) for 6 months. All children will be advised to reduce weight (dietetic intervention + increased physical activity). Laboratory tests, liver ultrasound, anthropometric analysis will be performed at the start, after 3 months and 6 months.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 6-19
  • overweight or obesity
  • ALT activity over 130% of upper limit norm
  • hyperechogenicity of the liver on ultrasound

Exclusion Criteria:

  • HCV, HBV infection
  • cholestasis
  • chronic/acute liver failure
  • alpha-1-antitrypsin deficiency
  • Wilson disease
  • type 2 diabetes mellitus
  • beta-oxidation defects
  • alcohol consumption
  • history of parenteral nutrition
  • use of drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fish oil
Children will receive fish oil capsules according to age as described in the protocol
Dietary supplement: Fish Oil
Fish oil given in supplementary dose
Placebo Comparator: Placebo
Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules
Dietary supplement: Fish Oil
Fish oil given in supplementary dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum alanine transaminase level decrease min. 0.3 upper limit of normal
Time Frame: 6 months
Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
normalization of liver imaging on ultrasound
Time Frame: after 6 months of therapy
'Fish oil' group will be compared to 'placebo' group
after 6 months of therapy
ALT and AST activity
Time Frame: 6 months
'Fish oil' group will be compared to 'placebo' group
6 months
Insulin resistance markers as Homa-IR
Time Frame: 6 months
'Fish oil' group will be compared to 'placebo' group
6 months
Fat and lean body mass measurements
Time Frame: 6 months
'Fish oil' group will be compared to 'placebo' group
6 months
Caloric intake including fat intake and sucrose intake
Time Frame: 6 months
'Fish oil' group will be compared to 'placebo' group
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piotr Socha

Collaborators

Medical University of Silesia
Medical University of Bialystok
Pediatric Municipal Hospital of Rzeszow, Poland

Investigators

  • Principal Investigator: Piotr Socha, Children's Memorial Health Institute, Warsaw, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChildrensMHIPoland

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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