Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study

NCT01285362 | Completed Results

• 1 other identifier: AAAF0695
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Fatty Liver Disease; Hepatic Steatosis; Docosahexaenoic Acid; Eicosapentanoic Acid; Omega-3 Fatty Acids; Elevated Transaminases; Fish oil supplements

Outcome Measures

Primary Outcomes (1)

• Participants With Normalized Liver Enzyme Levels

  To evaluate the number of participants (young adults with obesity related NAFLD) that will normalize their elevated liver enzyme levels (normalized defined as having liver enzyme levels within a normal laboratory range) with supplements of fish oil (n-3 FA containing eicosapentanoic acid and docosahexaenoic acid).

  Up to 12 months from entry into the study

Secondary Outcomes (2)

• Number of Participants With Normalization of Plasma Lipid Levels

  Up to 12 months from entry into the study

• Number of Participants With Insulin Resistance Attenuated

  Up to 12 months from entry into the study

Study Arms (2)

Fish Oil Supplementation (Group A)

ACTIVE COMPARATOR

Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of docosahexaenoic acid (DHA).

Drug: Fish Oil Supplementation

Placebo Supplementation (Group B)

PLACEBO COMPARATOR

Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.

Drug: Placebo Supplementation

Interventions

Fish Oil Supplementation DRUG

Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.

Also known as: Fish Oil Pills

Fish Oil Supplementation (Group A)

Placebo Supplementation DRUG

Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.

Also known as: Placebo Pills

Placebo Supplementation (Group B)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Irving Clinical Research Center (GCRC) at Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr Mercedes Martinez
• Organization: Columbia Universty

mm2479@cumc.columbia.edu

212-305-3438

Study Officials

• Mercedes Martinez, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 28, 2011
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 5, 2022
• Results First Posted: May 5, 2022

Record last verified: 2022-05

Locations

US (1)