Status:
COMPLETED
Effect of Omega-3 PUFA Supplementation in NAFLD Patients
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids will decrease the amount of fat in liver.
Detailed Description
NAFLD is the most common liver disease in the United States and is also a common cause of abnormal liver tests in the United States. NAFLD includes mild as well as a more severe nonalcoholic fatty liv...
Eligibility Criteria
Inclusion
- Acceptance into NASH CRN Database Study
- Exclusion from or unwillingness to participate in the NASH CRN PIVENS Study
- Histological diagnosis or imaging study suggesting NAFLD with at least 20% steatosis
- Willingness to maintain study diet for duration of the study
- At least 18 years of age
- No contraindication for MRI scanning (i.e., pacemaker, shunts etc)
Exclusion
- Use of lipid lowering drugs (i.e., statins and fibrate drugs)
- Use of insulin or thiazolidinediones
- Use of drugs possibly associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, or other known hepatotoxins) for more than 2 consecutive weeks in the 2 years prior to screening
- Initiation of anti-diabetic drugs (insulin, biguanides, sulfonylureas, metformin, thiazolidinediones) in the 3 months prior to randomization
- Initiation of anti-NASH drugs (thiazolidinediones, vitamin E, metformin, UDCA, SAM-e, betaine, milk thistle, gemfibrozil, anti-TNF therapies, probiotics) in the 3 months prior to randomization
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00230113
Start Date
September 1 2005
End Date
June 1 2010
Last Update
July 10 2013
Active Locations (1)
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1
University of Washington Medical Center
Seattle, Washington, United States, 98195