Study of Fish Oil to Reduce ALT Levels in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00694746
Recruitment Status : Terminated (Study closed for slow recruitment)
First Posted : June 10, 2008
Last Update Posted : January 29, 2016
Information provided by (Responsible Party):
Carine Lenders, Boston University

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Fatty Liver Drug: Omega-3-acid ethyl esters Drug: Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents
Study Start Date : June 2008
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
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:
  • Omacor
  • Lovaza

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 Name: corn oil

Primary Outcome Measures :
  1. Efficacy parameters: Characterize the reduction in ALT levels. [ Time Frame: 3 and 6 months from baseline ]
  2. 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. [ Time Frame: From baseline to end of treatment ]

Secondary Outcome Measures :
  1. Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters. [ Time Frame: 3 and 6 months from baseline ]

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00694746

United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Principal Investigator: Carine M Lenders, MD, MS, ScD Boston University

Responsible Party: Carine Lenders, Carine Lenders, MD, MS, ScD, Boston University Identifier: NCT00694746     History of Changes
Other Study ID Numbers: IIT40
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Design with difficult enrollement

Keywords provided by Carine Lenders, Boston University:
Non-Alcoholic Fatty Liver Disease

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases