Study of Fish Oil to Reduce ALT Levels in Adolescents

NCT ID: NCT00694746

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2014-03-31

Brief Summary

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.

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.

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Omega-3-acid ethyl esters

Intervention Type: DRUG

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)

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

Omacor; Lovaza; corn oil

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Carine Lenders

Carine Lenders, MD, MS, ScD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carine M Lenders, MD, MS, ScD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IIT40

Identifier Type: -

Identifier Source: org_study_id