NCT00694746

Study of Fish Oil to Reduce ALT Levels in Adolescents

Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)
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)

Timeline

• Start date: 2008-06-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2008-06-10
• Last updated: 2016-01-29

Locations

1 site across 1 country: United States