N/A
N=8
Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study
Non-Alcoholic Fatty Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT01285362 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Participants With Normalized Liver Enzyme Levels — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fish Oil Supplementation (Drug); Placebo Supplementation (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Normalized Liver Enzyme Levels |
0; 0 | — |
| SECONDARY Number of Participants With Normalization of Plasma Lipid Levels |
0; 0 | — |
| SECONDARY Number of Participants With Insulin Resistance Attenuated |
— | — |
Summary
Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic fatty liver disease (NAFLD). The liver pathology encompasses a range from isolated fatty liver to advanced fibrosis, cirrhosis and end-stage liver disease. Weight loss, particularly if gradual, may lead to improvement in liver histology. Unfortunately, few patients in the pediatric population are willing to follow these recommendations and achieve weight loss. Medical treatment directed specifically at the liver disease has only recently been investigated and approved in patients with NAFLD. The beneficial effects of fish oil are attributed to its high concentrations of n - 3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are major regulators of pathways that participate in decreased production and break down of triglycerides and fatty acids in the liver. The investigators hypothesize that children with obesity related NAFLD will normalize elevated liver enzymes, plasma lipid levels, and attenuate insulin resistance with supplements of n-3 fatty acids. If this hypothesis is proven true, then fish oil could be used to treat NAFLD and to prevent the deterioration of fatty liver into end-stage liver disease.
Eligibility Criteria
Inclusion Criteria
- Body Mass Index (BMI i.e. wt(Kg)/ht(m)2) above the 95th % as defined by the NHANES tables.
- Elevated liver enzymes (ALT and/or AST) to at least 1.5 times the upper limit on at least 2 examinations, (ALT, the upper limit of normal values in our laboratory is 41 U/L; AST, upper limit of normal values in our laboratory is 38 U/L).
- Subjects must demonstrate ability to swallow capsules.
Exclusion Criteria
- Overt Diabetes
- Viral or autoimmune hepatitis, Wilson's disease, Alpha-1 antitrypsin deficiency, hemochromatosis or any other form of chronic liver disease not related to NAFLD
- Exposure to drugs or hepatotoxins less than 14 days prior to recruitment
- Alcohol consumption > 20 grams/day
- Evidence of cirrhosis on liver biopsy.
Data sourced from ClinicalTrials.gov (NCT01285362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.