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

This study has been completed.
Sponsor:
Collaborators:
Medical University of Bialystok
Medical University of Katowice, Poland
Pediatric Municipal Hospital of Rzeszow, Poland
Information provided by (Responsible Party):
Piotr Socha, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier:
NCT01547910
First received: February 29, 2012
Last updated: August 19, 2014
Last verified: August 2014

February 29, 2012
August 19, 2014
August 2007
March 2012   (final data collection date for primary outcome measure)
Serum alanine transaminase level decrease min. 0.3 upper limit of normal [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group
Same as current
Complete list of historical versions of study NCT01547910 on ClinicalTrials.gov Archive Site
  • normalization of liver imaging on ultrasound [ Time Frame: after 6 months of therapy ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
  • ALT and AST activity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
  • Insulin resistance markers as Homa-IR [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
  • Fat and lean body mass measurements [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
  • Caloric intake including fat intake and sucrose intake [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
  • normalization of liver imaging on utrasound [ Time Frame: after 6 months of therapy ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
  • ALT and AST activity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
  • Insulin resistance markers as Homa-IR [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
  • Fat and lean body mass measurements [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
  • Caloric intake including fat intake and sucrose intake [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    'Fish oil' group will be compared to 'placebo' group
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-alcoholic Fatty Liver Disease
Dietary Supplement: Fish Oil
Fish oil given in supplementary dose
  • Experimental: Fish oil
    Children will receive fish oil capsules according to age as described in the protocol
    Intervention: Dietary Supplement: Fish Oil
  • Placebo Comparator: Placebo
    Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules
    Intervention: Dietary Supplement: Fish Oil
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
April 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
6 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01547910
ChildrensMHIPoland
Yes
Piotr Socha, Children's Memorial Health Institute, Poland
Piotr Socha
  • Medical University of Bialystok
  • Medical University of Katowice, Poland
  • Pediatric Municipal Hospital of Rzeszow, Poland
Principal Investigator: Piotr Socha Children's Memorial Health Institute, Warsaw, Poland
Children's Memorial Health Institute, Poland
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP