Back to resultsEffect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fish Oil
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring fatty liver, hepatitis, insulin resistance, unsaturated fatty acids, NAFLD, children
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fish oil
Placebo
Arm Description
Children will receive fish oil capsules according to age as described in the protocol
Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
normalization of liver imaging on ultrasound
'Fish oil' group will be compared to 'placebo' group
ALT and AST activity
'Fish oil' group will be compared to 'placebo' group
Insulin resistance markers as Homa-IR
'Fish oil' group will be compared to 'placebo' group
Fat and lean body mass measurements
'Fish oil' group will be compared to 'placebo' group
Caloric intake including fat intake and sucrose intake
'Fish oil' group will be compared to 'placebo' group
Full Information
NCT ID
NCT01547910
First Posted
February 29, 2012
Last Updated
August 19, 2014
Sponsor
Piotr Socha
Collaborators
Medical University of Bialystok, Medical University of Silesia, Pediatric Municipal Hospital of Rzeszow, Poland
1. Study Identification
Unique Protocol Identification Number
NCT01547910
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Piotr Socha
Collaborators
Medical University of Bialystok, Medical University of Silesia, Pediatric Municipal Hospital of Rzeszow, Poland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
fatty liver, hepatitis, insulin resistance, unsaturated fatty acids, NAFLD, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish oil
Arm Type
Experimental
Arm Description
Children will receive fish oil capsules according to age as described in the protocol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Intervention Description
Fish oil given in supplementary dose
Primary Outcome Measure Information:
Title
Serum alanine transaminase level decrease min. 0.3 upper limit of normal
Description
Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
normalization of liver imaging on ultrasound
Description
'Fish oil' group will be compared to 'placebo' group
Time Frame
after 6 months of therapy
Title
ALT and AST activity
Description
'Fish oil' group will be compared to 'placebo' group
Time Frame
6 months
Title
Insulin resistance markers as Homa-IR
Description
'Fish oil' group will be compared to 'placebo' group
Time Frame
6 months
Title
Fat and lean body mass measurements
Description
'Fish oil' group will be compared to 'placebo' group
Time Frame
6 months
Title
Caloric intake including fat intake and sucrose intake
Description
'Fish oil' group will be compared to 'placebo' group
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Socha
Organizational Affiliation
Children's Memorial Health Institute, Warsaw, Poland
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25771388
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.
Results Reference
derived
PubMed Identifier
23702094
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.
Results Reference
derived
Learn more about this trial
Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children
We'll reach out to this number within 24 hrs