Clinical trial NCT00694746: Study of Fish Oil to Reduce ALT Levels in Adolescents
Official title: Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-alcoholic Fatty Liver Disease
Fatty Liver
Keywords: ALT
Non-Alcoholic Fatty Liver Disease
Adolescents
Overweight
Treatment
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-06-10
Enrollment: 3
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Efficacy parameters: Characterize the reduction in ALT levels.
timeFrame: 3 and 6 months from baseline
measure: Safety/compliance parameters: Describe the safety blood tests results, review of systems, and physical examination at baseline, mid point, and end of treatment, as well as identify adverse events and compliance parameters at study contacts.
timeFrame: From baseline to end of treatment
Secondary outcomes:
measure: Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters.
timeFrame: 3 and 6 months from baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Carine M Lenders, MD, MS, ScD
role: PRINCIPAL_INVESTIGATOR
References: