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Study of Fish Oil to Reduce ALT Levels in Adolescents

Primary Purpose

Non-alcoholic Fatty Liver Disease, Fatty Liver

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omega-3-acid ethyl esters
Placebo
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring ALT, Non-Alcoholic Fatty Liver Disease, Adolescents, Overweight, Treatment

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fish oil

Placebo

Arm Description

Omega-3-acid ethyl esters in the form of fish oil capsules with ram up from 1g to 4 g/day (capsules 1g)

Placebo

Outcomes

Primary Outcome Measures

Efficacy parameters: Characterize the reduction in ALT levels.
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.

Secondary Outcome Measures

Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters.

Full Information

First Posted
June 6, 2008
Last Updated
January 28, 2016
Sponsor
Boston University
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00694746
Brief Title
Study of Fish Oil to Reduce ALT Levels in Adolescents
Official Title
Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Study closed for slow recruitment
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease, Fatty Liver
Keywords
ALT, Non-Alcoholic Fatty Liver Disease, Adolescents, Overweight, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil
Arm Type
Experimental
Arm Description
Omega-3-acid ethyl esters in the form of fish oil capsules with ram up from 1g to 4 g/day (capsules 1g)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Omega-3-acid ethyl esters
Other Intervention Name(s)
Omacor, Lovaza
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
corn oil
Intervention Description
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)
Primary Outcome Measure Information:
Title
Efficacy parameters: Characterize the reduction in ALT levels.
Time Frame
3 and 6 months from baseline
Title
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 Measure Information:
Title
Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters.
Time Frame
3 and 6 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carine M Lenders, MD, MS, ScD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Design with difficult enrollement

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Study of Fish Oil to Reduce ALT Levels in Adolescents

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