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Completed

NCT Number: NCT01547910

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

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

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hepatitis Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

Fish oil given in supplementary dose

Primary outcomes

  1. 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

Secondary outcomes

  1. normalization of liver imaging on ultrasound

    Time frame: after 6 months of therapy

    'Fish oil' group will be compared to 'placebo' group

  2. ALT and AST activity

    Time frame: 6 months

    'Fish oil' group will be compared to 'placebo' group

  3. Insulin resistance markers as Homa-IR

    Time frame: 6 months

    'Fish oil' group will be compared to 'placebo' group

  4. Fat and lean body mass measurements

    Time frame: 6 months

    'Fish oil' group will be compared to 'placebo' group

  5. Caloric intake including fat intake and sucrose intake

    Time frame: 6 months

    'Fish oil' group will be compared to 'placebo' group

Sponsors and collaborators

Lead sponsor

Piotr Socha

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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