Study of Fish Oil to Reduce ALT Levels in Adolescents - Full Text View

Sponsors and Collaborators:	Boston University GlaxoSmithKline
Information provided by:	Boston University
ClinicalTrials.gov Identifier:	NCT00694746

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 I

MedlinePlus related topics: Liver Diseases

Drug Information available for: Omacor Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents

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
1: Experimental 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)
2: 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)

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

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

Responsible Party:	Boston University School of Medicine ( Carine Lenders, MD, MS, PI )
Study ID Numbers:	IIT40, H-26702
Study First Received:	June 6, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00694746
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

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic steatohepatitis (NASH)
Digestive System Diseases
Overweight
Fatty Liver

ClinicalTrials.gov processed this record on January 16, 2009