Status:
TERMINATED
Study of Fish Oil to Reduce ALT Levels in Adolescents
Lead Sponsor:
Boston University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Non-alcoholic Fatty Liver Disease
Fatty Liver
Eligibility:
All Genders
13-17 years
Phase:
PHASE1
Brief 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 p...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00694746
Start Date
June 1 2008
End Date
March 1 2014
Last Update
January 29 2016
Active Locations (1)
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1
Boston University Medical Center
Boston, Massachusetts, United States, 02118