Study of Fish Oil to Reduce ALT Levels in Adolescents

NCT00694746 | Terminated Phase 1

• 1 other identifier: IIT40
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Keywords

ALT; Non-Alcoholic Fatty Liver Disease; Adolescents; Overweight; Treatment

Outcome Measures

Primary Outcomes (2)

• Efficacy parameters: Characterize the reduction in ALT levels.

  3 and 6 months from baseline

• 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.

  From baseline to end of treatment

Secondary Outcomes (1)

• Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters.

  3 and 6 months from baseline

Study Arms (2)

Fish oil

EXPERIMENTAL

Omega-3-acid ethyl esters in the form of fish oil capsules with ram up from 1g to 4 g/day (capsules 1g)

Drug: Omega-3-acid ethyl esters

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Omega-3-acid ethyl esters DRUG

Participants will receive 2 capsules of 1 gram of fish oil with meals twice a day for a period of six months (including a ramp up period of three weeks)

Also known as: Omacor, Lovaza

Fish oil

Placebo DRUG

Participants will receive 2 capsules of 1 gram of placebo with meals twice a day for a period of six months (including a ramp up period of three weeks)

Also known as: corn oil

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Boston University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Overweight

Interventions

Omacor; Corn Oil

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Carine M Lenders, MD, MS, ScD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carine Lenders, MD, MS, ScD

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 29, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)