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Completed
NCT00230113
Effect of Omega-3 PUFA Supplementation in NAFLD Patients
Conditions: Non-Alcoholic Fatty Liver Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Location: University of Washington Medical Center Seattle Washington
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT00230113). StuddyBuddy aggregates publicly available trial information.