This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).
Adults age 18 years or older will be enrolled for 48 weeks and treated with 200 international units (IU), 400 IU, or 800 IU of Vitamin E or matching placebo for 24 weeks. The primary objective of the study is to determine the minimum effective dose of Vitamin E (d-alpha-tocopherol) based upon relative change in alanine aminotransferase (ALT) from baseline to 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
University of California, San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Relative Change in Alanine Aminotransferase (ALT) From Baseline to 24 Weeks
Percent change from baseline to 24 weeks relative to baseline measure of ALT.
Time frame: Baseline to 24 weeks (end of treatment)
Proportion of Patients Achieving Normalization of Alanine Aminotransferase (ALT) at 24 Weeks
Normalization of ALT (U/L) is defined as a decrease in ALT to less than or equal to the ULN at the 24 week visit among participants who had an ALT value greater than ULN at baseline. Values for upper limits of normal (ULN) are defined at each clinical center per institutional guidelines.
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Serum Alanine Aminotransferase (ALT) From Baseline
ALT value in U/L
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Serum Aspartate Aminotransferase (AST) From Baseline
AST value in U/L
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Hepatic Steatosis (Fat in the Liver) Determined by Fibroscan® Controlled Attenuation Parameter (CAP) Software Function
CAP (Control Attenuation Parameter) is expressed in decibels per meter (dB/m). This value is the median of all valid measurements performed during the examination. It ranges from 100 to 400 dB/m. Higher dB/m indicates worse liver fat.
Time frame: Baseline to24 weeks (end of treatment)
Mean Change in Liver Stiffness From Baseline Assessed by Fibroscan®
Fibroscan® measures stiffness in kiloPascal's (kPa) and ranges from 2 to 75. Normal range of FibroScan is between 2 to 7 kPa, and the average normal result is 5.3kPa. Higher kPa means more stiffness (scarring).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indiana University- Adults
Indianapolis, Indiana, United States
St. Louis University
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Liver Institute Northwest
Seattle, Washington, United States
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Gamma-glutamyl Transferase (GGT) From Baseline to 24 Weeks
GGT is measured in U/L
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Glucose From Baseline to 24 Weeks
Fasting glucose measured in mg/dL
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Weight From Baseline to 24 Weeks
Weight measured in kilograms (kg)
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Body Mass Index (BMI) From Baseline to 24 Weeks
BMI is reported in kg/m-squared
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Waist Circumference From Baseline to 24 Weeks
Waist circumference measured in centimeters (cm)
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Waist-to-hip Ratio From Baseline to 24 Weeks
Waist-to-hip ratio from baseline to 24 weeks
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Liver Symptom Questionnaire Total Score
The Liver Symptom Questionnaire scores 10 symptoms of liver disease on a scale of 1-5. Higher scores mean higher symptom severity. Total score can range from 10-50.
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in ALT From 24 to 48 Weeks
Change in ALT (U/L) during off treatment phase
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in AST From 24 to 48 Weeks
AST value in U/L
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in GGT From 24 to 48 Weeks
GGT is measured in U/L
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in Controlled Attenuation Parameter (CAP) From 24 to 48 Weeks
CAP (Control Attenuation Parameter) is expressed in decibels per meter (dB/m). This value is the median of all valid measurements performed during the examination. It ranges from 100 to 400 dB/m. Higher dB/m indicates worse liver fat.
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in Liver Stiffness Measure (LSM) From 24 to 48 Weeks
LSM is measured in kPa
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)