205
Participants
Start Date
January 3, 2020
Primary Completion Date
September 1, 2022
Study Completion Date
September 1, 2022
Vitamin E [(all-rac)-α-tocopheryl acetate]
Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months
Omega-3 fatty acid (DHA EE)
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate]
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
Placebo
Matching soybean placebo (3 capsules) of all arms daily for 6 months.
M3 Wake Research Associates, Raleigh
Summit Clinical Research LLC, Athens
Indago Research and Health Center, Inc., Hialeah
Advanced Pharma CR LLC, Miami
Med-Care Research, Miami
Integrity Clinical Research LLC, Doral
Florida Research Institute, Lakewood Rch
Indiana University School of Medicine, Indianapolis
Arkansas Gastroenterology, North Little Rock
Centex Studies, Inc., Houston
Liver Specialists of Texas/Mt. Olympus Medical Research, Houston
American Research Corporation at the Texas Liver Institute, San Antonio
Arizona Liver Health, Chandler
Arizona Liver Health, Tucson
Inland Empire Clinical Trials, LLC, Rialto
DSM Nutritional Products, Inc.
INDUSTRY
Naga P. Chalasani
OTHER