Study of Fish Oil to Reduce ALT Levels in Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Boston University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00694746
First received: June 6, 2008
Last updated: June 9, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Non-Alcoholic Fatty Liver Disease
Fatty Liver
Drug: Omega-3-acid ethyl esters
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Efficacy parameters: Characterize the reduction in ALT levels. [ Time Frame: 3 and 6 months from baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters. [ Time Frame: 3 and 6 months from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: June 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Omega-3-acid ethyl esters
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: 2
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)

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694746

Contacts
Contact: Lauren Oliver, MS, RD, LDN 617-414-4557 lauren.oliver@bmc.org

Locations
United States, Massachusetts
Boston University Medical School Recruiting
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
GlaxoSmithKline
Investigators
Principal Investigator: Carine M Lenders, MD, MS Boston University
  More Information

No publications provided

Responsible Party: Carine Lenders, MD, MS, PI, Boston University School of Medicine
ClinicalTrials.gov Identifier: NCT00694746     History of Changes
Other Study ID Numbers: IIT40, H-26702
Study First Received: June 6, 2008
Last Updated: June 9, 2008
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Boston University:
ALT
Non-Alcoholic Fatty Liver Disease
Adolescents
Overweight
Treatment

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 22, 2014