Study of Fish Oil to Reduce ALT Levels in Adolescents

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University
• Collaborator: GlaxoSmithKline

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