Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Medical University of Bialystok
Medical University of Katowice, Poland
Pediatric Municipal Hospital of Rzeszow, Poland
Information provided by (Responsible Party):
Piotr Socha, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier:
NCT01547910
First received: February 29, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Non-alcoholic Fatty Liver Disease
Dietary Supplement: Fish Oil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children - a Randomized, Double Blind, Placebo Controlled, Multicenter Study

Resource links provided by NLM:


Further study details as provided by Children's Memorial Health Institute, Poland:

Primary Outcome Measures:
  • Serum alanine transaminase level decrease min. 0.3 upper limit of normal [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group


Secondary Outcome Measures:
  • normalization of liver imaging on ultrasound [ Time Frame: after 6 months of therapy ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group

  • ALT and AST activity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group

  • Insulin resistance markers as Homa-IR [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group

  • Fat and lean body mass measurements [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group

  • Caloric intake including fat intake and sucrose intake [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group


Enrollment: 76
Study Start Date: August 2007
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547910

Sponsors and Collaborators
Piotr Socha
Medical University of Bialystok
Medical University of Katowice, Poland
Pediatric Municipal Hospital of Rzeszow, Poland
Investigators
Principal Investigator: Piotr Socha Children's Memorial Health Institute, Warsaw, Poland
  More Information

No publications provided by Children's Memorial Health Institute, Poland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Piotr Socha, Professor PhD MD, Principal Investigator, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier: NCT01547910     History of Changes
Other Study ID Numbers: ChildrensMHIPoland
Study First Received: February 29, 2012
Last Updated: August 19, 2014
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Children's Memorial Health Institute, Poland:
fatty liver
hepatitis
insulin resistance
unsaturated fatty acids
NAFLD, children

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on November 25, 2014