Trial | NCT01547910  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fish oil ...

  • Study Participants

    76
The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.
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 Started
Aug 31
2007
Primary Completion
Mar 31
2012
Study Completion
Apr 30
2012
Last Update
Aug 21
2014
Estimate

Dietary Supplement Fish Oil

Fish oil given in supplementary dose

Fish oil Experimental

Children will receive fish oil capsules according to age as described in the protocol

Placebo Placebo Comparator

Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules

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
No Results Posted