Study of Fish Oil to Reduce ALT Levels in Adolescents

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Non-alcoholic Fatty Liver Disease, Fatty Liver

In brief

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.

Key facts

Study ID

NCT00694746

Run by

Boston University

People needed

3

Starts

2008-06-01

Expected to finish

2014-03-01

Last updated by the study team

2016-01-29

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Boston University Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.