Study of Fish Oil to Reduce ALT Levels in Adolescents

Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents

This trial will provide preliminary data to test the hypothesis that a six-month treatment period with fish oil for overweight adolescent with mild to moderate persistent elevation of ALT levels and presence of hepatic steatosis on CT-scan is safe and will result in decreased ALT.

Study Overview

• Status: Terminated
• Conditions: Fatty Liver; Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Omega-3-acid ethyl esters; Drug: Placebo

Detailed Description

Over the past two decades, pre-adult nonalcoholic fatty liver disease (NAFLD) has emerged from the relative obscurity to become the most common cause of liver disease in pediatric patients. Currently, over 17% of US children and adolescents have a BMI at or greater than the 95th percentile for age and gender and 20% of children in weight management programs are estimated to have NAFLD. Untreated NAFLD can lead to fibrosis and to established cirrhosis in children as young as 10. Fish oils are a rich source of omega-3-acid ethyl esters or n-3 long-chain polyunsaturated fatty acids, and increasing evidence suggest they may safely improve hepatic steatosis. Given the prevalence of obesity, of NAFLD, and the severe, progressive nature of this condition, effective treatment strategies are urgently needed. We plan to gather preliminary data on the efficacy and safety of fish oil supplements in reducing persistent elevation of ALT levels and hepatic steatosis on abdominal CT-scan among urban youth (BMI>=95th percentile). This preliminary data will provide the necessary information to calculate the sample size for a phase 2 trial.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI (kg/m2) at or above the 95th percentile for age and gender
• Weight below 400 pounds (less than 182 kilograms)
• Persistent elevation of ALT (41-90 UI/L at study screening)
• Presence of hepatic steatosis on abdominal CT-scan
• Able to give informed consent/assent

Exclusion Criteria:

• Type 2 diabetes mellitus
• Prior drug treatment for diabetes, insulin insensitivity, or weight loss medications six months before screening
• Use of prescription strength glucocorticoids within three months before screening
• History of syndrome or medical disorder associated with significant obesity
• Participation in a weight loss program within six months of screening resulting in 5% or more weight loss
• History of weight loss surgery
• Alcohol use more than twice weekly or more than 3 alcohol containing beverages within a 24-hour period in the past six months
• Known or suspected bleeding condition
• History of liver disease including prior liver biopsy with NASH type 2 or cirrhosis
• Former or present positive blood tests for Infectious hepatitis B or C, autoimmune hepatitis, Wilson disease, Alpha-1 anti-trypsin deficiency, Iron storage disease, or high TSH
• History of past or current pregnancy
• Use of illegal/illicit drugs
• Other conditions contraindicated or cause for caution in the use of fish oil
• Unable to comply with the protocol
• Any other serious disease determined by the study gastroenterologists and physician nutrition specialist as potential study risk for the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Participants will receive 2 capsules of 1 gram of placebo with meals twice a day for a period of six months (including a ramp up period of three weeks); Other Names: corn oil
Experimental: Fish oil; Omega-3-acid ethyl esters in the form of fish oil capsules with ram up from 1g to 4 g/day (capsules 1g)	Drug: Omega-3-acid ethyl esters; Participants will receive 2 capsules of 1 gram of fish oil with meals twice a day for a period of six months (including a ramp up period of three weeks); Other Names: Lovaza; Omacor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy parameters: Characterize the reduction in ALT levels.	3 and 6 months from baseline
Safety/compliance parameters: Describe the safety blood tests results, review of systems, and physical examination at baseline, mid point, and end of treatment, as well as identify adverse events and compliance parameters at study contacts.	From baseline to end of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters.	3 and 6 months from baseline

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Carine M Lenders, MD, MS, ScD, Boston University

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 6, 2008
• First Submitted That Met QC Criteria: June 9, 2008
• First Posted (Estimate): June 10, 2008

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Adolescents; Treatment; Overweight; ALT; Non-Alcoholic Fatty Liver Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: IIT40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Design with difficult enrollement