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

Piotr Socha

Status and phase: Completed; Phase 2

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Fish Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01547910

ChildrensMHIPoland

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 6 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

Fish oil

Experimental group

Description:

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

Treatment:

Dietary Supplement: Fish Oil

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Fish Oil