NCT00323414View on ClinicalTrials.gov

Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver

PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Fatty Liver
Interventions
DRUG

Polyunsaturated fatty acid (Opti-EPA)

Active experimental arm to patients with diabetes mellitus and non alcoholic steatohepatitis: Eicosapentaenoic acid (EPA):Docosahexaenoic acid (DHA)\[360 mg EPA and 240 DHA in each capsule\] 6 capsules-3 capsules by mouth 2 x per day x 48 weeks

DRUG

Placebo

Placebo gelcaps containing corn oil identical to the PUFA gelcaps 6 capsules-3 capsules by mouth 2x per day x 48 weeks

Trial Locations (2)

44109

MetroHealth Medical Center, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

All Listed Sponsors
lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

NCT00323414 - Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver | Biotech Hunter | Biotech Hunter