Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children
1 other identifier
interventional
76
0 countries
N/A
Brief Summary
The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2007
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedAugust 21, 2014
August 1, 2014
4.6 years
February 29, 2012
August 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
normalization of liver imaging on ultrasound
after 6 months of therapy
ALT and AST activity
6 months
Insulin resistance markers as Homa-IR
6 months
Fat and lean body mass measurements
6 months
Caloric intake including fat intake and sucrose intake
6 months
Study Arms (2)
Fish oil
EXPERIMENTALChildren will receive fish oil capsules according to age as described in the protocol
Placebo
PLACEBO COMPARATORSunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules
Interventions
Eligibility Criteria
You may qualify if:
- age 6-19
- overweight or obesity
- ALT activity over 130% of upper limit norm
- hyperechogenicity of the liver on ultrasound
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Piotr Sochalead
- Medical University of Bialystokcollaborator
- Medical University of Silesiacollaborator
- Pediatric Municipal Hospital of Rzeszow, Polandcollaborator
Related Publications (2)
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.
PMID: 25771388DERIVEDJanczyk 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.
PMID: 23702094DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piotr Socha
Children's Memorial Health Institute, Warsaw, Poland
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor PhD MD, Principal Investigator
Study Record Dates
First Submitted
February 29, 2012
First Posted
March 8, 2012
Study Start
August 1, 2007
Primary Completion
March 1, 2012
Study Completion
April 1, 2012
Last Updated
August 21, 2014
Record last verified: 2014-08