Trial Outcomes & Findings for Vitamin E Dosing Study (NCT NCT04801849)
NCT ID: NCT04801849
Last Updated: 2026-05-14
Results Overview
Percent change from baseline to 24 weeks relative to baseline measure of ALT.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Baseline to 24 weeks (end of treatment)
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
Vitamin E, 200 IU
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 400 IU
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
51
|
48
|
|
Overall Study
COMPLETED
|
49
|
49
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
2
|
Reasons for withdrawal
| Measure |
Vitamin E, 200 IU
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 400 IU
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Vitamin E Dosing Study
Baseline characteristics by cohort
| Measure |
Vitamin E, 200 IU
n=50 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 400 IU
n=51 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=51 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=48 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 14.4 • n=1512 Participants
|
48.2 years
STANDARD_DEVIATION 14.1 • n=504 Participants
|
45.5 years
STANDARD_DEVIATION 13.9 • n=2016 Participants
|
48.8 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
47.0 years
STANDARD_DEVIATION 13.9 • n=97 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=1512 Participants
|
21 Participants
n=504 Participants
|
15 Participants
n=2016 Participants
|
16 Participants
n=99 Participants
|
77 Participants
n=97 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=1512 Participants
|
30 Participants
n=504 Participants
|
36 Participants
n=2016 Participants
|
32 Participants
n=99 Participants
|
123 Participants
n=97 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=1512 Participants
|
9 Participants
n=504 Participants
|
8 Participants
n=2016 Participants
|
8 Participants
n=99 Participants
|
34 Participants
n=97 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=1512 Participants
|
42 Participants
n=504 Participants
|
42 Participants
n=2016 Participants
|
40 Participants
n=99 Participants
|
165 Participants
n=97 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
1 Participants
n=97 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
1 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
9 Participants
n=2016 Participants
|
7 Participants
n=99 Participants
|
25 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
2 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
2 Participants
n=97 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=1512 Participants
|
41 Participants
n=504 Participants
|
41 Participants
n=2016 Participants
|
34 Participants
n=99 Participants
|
150 Participants
n=97 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
3 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=1512 Participants
|
4 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
5 Participants
n=99 Participants
|
17 Participants
n=97 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=1512 Participants
|
51 participants
n=504 Participants
|
51 participants
n=2016 Participants
|
48 participants
n=99 Participants
|
200 participants
n=97 Participants
|
|
Alanine Aminotransferase (ALT)
|
94 U/L
n=1512 Participants
|
87 U/L
n=504 Participants
|
85 U/L
n=2016 Participants
|
88 U/L
n=99 Participants
|
89 U/L
n=97 Participants
|
|
Aspartate Aminotransferase (AST)
|
56 U/L
n=1512 Participants
|
53 U/L
n=504 Participants
|
50 U/L
n=2016 Participants
|
48 U/L
n=99 Participants
|
52 U/L
n=97 Participants
|
|
Liver stiffness
|
9 kPa
n=1512 Participants
|
8 kPa
n=504 Participants
|
7 kPa
n=2016 Participants
|
8 kPa
n=99 Participants
|
8 kPa
n=97 Participants
|
|
Controlled Attenuation Parameter (CAP) score
|
318 dB/m
n=1512 Participants
|
321 dB/m
n=504 Participants
|
321 dB/m
n=2016 Participants
|
320 dB/m
n=99 Participants
|
321 dB/m
n=97 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
Percent change from baseline to 24 weeks relative to baseline measure of ALT.
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Relative Change in Alanine Aminotransferase (ALT) From Baseline to 24 Weeks
|
-36.3 % change
Standard Deviation 31.1
|
-36.4 % change
Standard Deviation 43.1
|
-12.2 % change
Standard Deviation 33.4
|
-38.4 % change
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks). Note: all participants had an ALT value greater than ULN at baseline.
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.
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Proportion of Patients Achieving Normalization of Alanine Aminotransferase (ALT) at 24 Weeks
|
18 Participants
|
24 Participants
|
10 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
ALT value in U/L
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Serum Alanine Aminotransferase (ALT) From Baseline
|
-43.5 U/L
Standard Deviation 48.8
|
-42.9 U/L
Standard Deviation 58.5
|
-12.4 U/L
Standard Deviation 33.5
|
-42.3 U/L
Standard Deviation 42.4
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
AST value in U/L
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Serum Aspartate Aminotransferase (AST) From Baseline
|
-24.4 U/L
Standard Deviation 46.4
|
-23.7 U/L
Standard Deviation 31.7
|
-3.3 U/L
Standard Deviation 20.3
|
-22.1 U/L
Standard Deviation 32.9
|
SECONDARY outcome
Timeframe: Baseline to24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 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.
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Hepatic Steatosis (Fat in the Liver) Determined by Fibroscan® Controlled Attenuation Parameter (CAP) Software Function
|
-9.0 dB/m
Standard Deviation 41.2
|
-20.1 dB/m
Standard Deviation 47.3
|
-11.2 dB/m
Standard Deviation 45.8
|
-26.0 dB/m
Standard Deviation 46.3
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
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).
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Liver Stiffness From Baseline Assessed by Fibroscan®
|
-1.2 kPa
Standard Deviation 4.3
|
-2.7 kPa
Standard Deviation 7.5
|
0.4 kPa
Standard Deviation 4.5
|
-0.7 kPa
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
GGT is measured in U/L
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Gamma-glutamyl Transferase (GGT) From Baseline to 24 Weeks
|
-25.1 U/L
Standard Deviation 53.0
|
-17.0 U/L
Standard Deviation 27.4
|
-19.8 U/L
Standard Deviation 63.8
|
-9.4 U/L
Standard Deviation 47.1
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
Fasting glucose measured in mg/dL
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Glucose From Baseline to 24 Weeks
|
3.0 mg/dL
Standard Deviation 30.3
|
3.2 mg/dL
Standard Deviation 19.6
|
4.3 mg/dL
Standard Deviation 41.0
|
1.2 mg/dL
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
Weight measured in kilograms (kg)
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Weight From Baseline to 24 Weeks
|
-1.7 kg
Standard Deviation 7.1
|
-1.0 kg
Standard Deviation 4.0
|
-1.3 kg
Standard Deviation 7.2
|
-1.9 kg
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
BMI is reported in kg/m-squared
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Body Mass Index (BMI) From Baseline to 24 Weeks
|
-0.6 kg/m-squared
Standard Deviation 2.0
|
-0.3 kg/m-squared
Standard Deviation 1.7
|
-0.2 kg/m-squared
Standard Deviation 2.4
|
-0.9 kg/m-squared
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
Waist circumference measured in centimeters (cm)
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Waist Circumference From Baseline to 24 Weeks
|
-1.0 cm
Standard Deviation 6.4
|
-1.8 cm
Standard Deviation 5.0
|
-0.1 cm
Standard Deviation 5.8
|
-1.2 cm
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
Waist-to-hip ratio from baseline to 24 weeks
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Waist-to-hip Ratio From Baseline to 24 Weeks
|
-0.001 ratio
Standard Deviation 0.052
|
-0.005 ratio
Standard Deviation 0.048
|
0.042 ratio
Standard Deviation 0.291
|
-0.008 ratio
Standard Deviation 0.041
|
SECONDARY outcome
Timeframe: Baseline to 24 weeks (end of treatment)Population: Participants who completed the treatment phase of the trial (baseline to 24 weeks).
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.
Outcome measures
| Measure |
Vitamin E, 400 IU
n=49 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=46 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=49 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Liver Symptom Questionnaire Total Score
|
-1.7 score difference
Standard Deviation 3.7
|
-1.2 score difference
Standard Deviation 2.3
|
-0.7 score difference
Standard Deviation 4.4
|
-1.4 score difference
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 24 weeks (end of treatment) to 48 weeks (final study visit)Population: Participants who completed the off-treatment phase of the trial (24 to 48 weeks).
Change in ALT (U/L) during off treatment phase
Outcome measures
| Measure |
Vitamin E, 400 IU
n=48 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=45 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=48 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in ALT From 24 to 48 Weeks
|
8.3 U/L
Standard Deviation 25.0
|
15.9 U/L
Standard Deviation 60.5
|
0.6 U/L
Standard Deviation 37.7
|
2.8 U/L
Standard Deviation 36.0
|
SECONDARY outcome
Timeframe: 24 weeks (end of treatment) to 48 weeks (final study visit)Population: Participants who completed the off-treatment phase of the trial (24 to 48 weeks).
AST value in U/L
Outcome measures
| Measure |
Vitamin E, 400 IU
n=48 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=45 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=48 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in AST From 24 to 48 Weeks
|
2.0 U/L
Standard Deviation 23.1
|
13.3 U/L
Standard Deviation 48.8
|
-0.9 U/L
Standard Deviation 27.4
|
2.1 U/L
Standard Deviation 26.2
|
SECONDARY outcome
Timeframe: 24 weeks (end of treatment) to 48 weeks (final study visit)Population: Participants who completed the off-treatment phase of the trial (24 to 48 weeks).
GGT is measured in U/L
Outcome measures
| Measure |
Vitamin E, 400 IU
n=48 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=45 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=48 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in GGT From 24 to 48 Weeks
|
6.3 U/L
Standard Deviation 25.0
|
4.1 U/L
Standard Deviation 14.8
|
6.7 U/L
Standard Deviation 39.8
|
-7.2 U/L
Standard Deviation 39.8
|
SECONDARY outcome
Timeframe: 24 weeks (end of treatment) to 48 weeks (final study visit)Population: Participants who completed the off-treatment phase of the trial (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.
Outcome measures
| Measure |
Vitamin E, 400 IU
n=48 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=45 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=48 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Controlled Attenuation Parameter (CAP) From 24 to 48 Weeks
|
-4.1 dB/m
Standard Deviation 44.1
|
-2.8 dB/m
Standard Deviation 52.0
|
-3.2 dB/m
Standard Deviation 45.6
|
10.2 dB/m
Standard Deviation 42.0
|
SECONDARY outcome
Timeframe: 24 weeks (end of treatment) to 48 weeks (final study visit)Population: Participants who completed the off-treatment phase of the trial (24 to 48 weeks).
LSM is measured in kPa
Outcome measures
| Measure |
Vitamin E, 400 IU
n=48 Participants
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=48 Participants
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=45 Participants
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
Vitamin E, 200 IU
n=48 Participants
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
|---|---|---|---|---|
|
Mean Change in Liver Stiffness Measure (LSM) From 24 to 48 Weeks
|
-0.2 kPa
Standard Deviation 3.2
|
0.8 kPa
Standard Deviation 4.0
|
-0.4 kPa
Standard Deviation 4.3
|
-1.0 kPa
Standard Deviation 4.2
|
Adverse Events
Vitamin E, 200 IU
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Vitamin E, 400 IU
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Vitamin E, 800 IU
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vitamin E, 200 IU
n=50 participants at risk
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 400 IU
n=51 participants at risk
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=51 participants at risk
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=48 participants at risk
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/50 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Gastrointestinal disorders
Salivary gland infection
|
2.0%
1/50 • Number of events 1 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/50 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
2.1%
1/48 • Number of events 1 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Other, specify - Inflamed synovium of Right knee
|
2.0%
1/50 • Number of events 1 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Nervous system disorders
Intercranial hemorrhage
|
0.00%
0/50 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Renal and urinary disorders
Kidney infection
|
2.0%
1/50 • Number of events 1 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/50 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Surgical and medical procedures
Other, specify- gastric bypass
|
0.00%
0/50 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
Other adverse events
| Measure |
Vitamin E, 200 IU
n=50 participants at risk
200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 400 IU
n=51 participants at risk
400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Vitamin E, 800 IU
n=51 participants at risk
800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast
Vitamin E: Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
|
Placebo
n=48 participants at risk
matching placebo taken once daily with breakfast
Placebo: Participants will take a placebo vitamin E capsule daily for 24 weeks
|
|---|---|---|---|---|
|
General disorders
Flu-like symptoms
|
0.00%
0/50 • 48 weeks
|
2.0%
1/51 • Number of events 2 • 48 weeks
|
5.9%
3/51 • Number of events 3 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Infections and infestations
COVID-19 infection
|
6.0%
3/50 • Number of events 3 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
9.8%
5/51 • Number of events 5 • 48 weeks
|
6.2%
3/48 • Number of events 3 • 48 weeks
|
|
Infections and infestations
Upper respiratory infection
|
4.0%
2/50 • Number of events 2 • 48 weeks
|
3.9%
2/51 • Number of events 2 • 48 weeks
|
5.9%
3/51 • Number of events 3 • 48 weeks
|
4.2%
2/48 • Number of events 2 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
6.2%
3/48 • Number of events 3 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
3/50 • Number of events 3 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/48 • 48 weeks
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1 • 48 weeks
|
3.9%
2/51 • Number of events 2 • 48 weeks
|
7.8%
4/51 • Number of events 4 • 48 weeks
|
2.1%
1/48 • Number of events 1 • 48 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/50 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
5.9%
3/51 • Number of events 4 • 48 weeks
|
4.2%
2/48 • Number of events 2 • 48 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1 • 48 weeks
|
3.9%
2/51 • Number of events 2 • 48 weeks
|
3.9%
2/51 • Number of events 2 • 48 weeks
|
6.2%
3/48 • Number of events 4 • 48 weeks
|
Additional Information
Arun J. Sanyal, MD
Virginia Commonwealth University-Medical College of Virginia Campus
Phone: (804) 828-7811
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place