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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547910
• Other study ID #: ChildrensMHIPoland
• Status: Completed
• Phase: Phase 2
• First received: February 29, 2012
• Last updated: August 19, 2014
• Start date: August 2007
• Est. completion date: April 2012

Study information

• Verified date: August 2014
• Source: Children's Memorial Health Institute, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Fish Oil
Fish oil given in supplementary dose

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Piotr Socha	Medical University of Bialystok, Medical University of Silesia, Pediatric Municipal Hospital of Rzeszow, Poland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum alanine transaminase level decrease min. 0.3 upper limit of normal	Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group	6 months	No
Secondary	normalization of liver imaging on ultrasound	'Fish oil' group will be compared to 'placebo' group	after 6 months of therapy	Yes
Secondary	ALT and AST activity	'Fish oil' group will be compared to 'placebo' group	6 months	Yes
Secondary	Insulin resistance markers as Homa-IR	'Fish oil' group will be compared to 'placebo' group	6 months	Yes
Secondary	Fat and lean body mass measurements	'Fish oil' group will be compared to 'placebo' group	6 months	Yes
Secondary	Caloric intake including fat intake and sucrose intake	'Fish oil' group will be compared to 'placebo' group	6 months	Yes