Clinical trial NCT01547910: Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children
Official title: Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children - a Randomized, Double Blind, Placebo Controlled, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: fatty liver
hepatitis
insulin resistance
unsaturated fatty acids
NAFLD, children
Lead sponsor: Children's Memorial Health Institute, Poland
Sponsor class: OTHER
Collaborators: name: Medical University of Bialystok
name: Medical University of Silesia
name: Pediatric Municipal Hospital of Rzeszow, Poland
First posted: 2012-03-08
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Serum alanine transaminase level decrease min. 0.3 upper limit of normal
timeFrame: 6 months
Secondary outcomes:
measure: normalization of liver imaging on ultrasound
timeFrame: after 6 months of therapy
measure: ALT and AST activity
timeFrame: 6 months
measure: Insulin resistance markers as Homa-IR
timeFrame: 6 months
measure: Fat and lean body mass measurements
timeFrame: 6 months
measure: Caloric intake including fat intake and sucrose intake
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Children's Memorial Health Institute, Warsaw, Poland
name: Piotr Socha
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janczyk W, Lebensztejn D, Wierzbicka-Rucinska A, Mazur A, Neuhoff-Murawska J, Matusik P, Socha P. Omega-3 Fatty acids therapy in children with nonalcoholic Fatty liver disease: a randomized controlled trial. J Pediatr. 2015 Jun;166(6):1358-63.e1-3. doi: 10.1016/j.jpeds.2015.01.056. Epub 2015 Mar 11.
citation: Janczyk W, Socha P, Lebensztejn D, Wierzbicka A, Mazur A, Neuhoff-Murawska J, Matusik P. Omega-3 fatty acids for treatment of non-alcoholic fatty liver disease: design and rationale of randomized controlled trial. BMC Pediatr. 2013 May 23;13:85. doi: 10.1186/1471-2431-13-85.