Study of Fish Oil to Reduce ALT Levels in Adolescents

Boston University

Status and phase

Terminated

Phase 1

Conditions

Fatty Liver

Non-alcoholic Fatty Liver Disease

Treatments

Drug: Omega-3-acid ethyl esters

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00694746

IIT40

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No 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