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Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E

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ClinicalTrials.gov Identifier: NCT01792115
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : October 19, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Fatty Liver
Interventions Drug: Vitamin E 200 IU/d
Drug: Vitamin E 400 IU/d
Drug: Vitamin E 800 IU/d
Behavioral: Diet and Exercise
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Period Title: Overall Study
Started 7 7 8
Completed 7 6 8
Not Completed 0 1 0
Reason Not Completed
Lost to Follow-up             0             1             0
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800 Total
Hide Arm/Group Description

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Total of all reporting groups
Overall Number of Baseline Participants 7 7 8 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 8 participants 22 participants
52.3  (14.6) 43.9  (9.3) 48.4  (11.3) 48.2  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 8 participants 22 participants
Female
5
  71.4%
3
  42.9%
2
  25.0%
10
  45.5%
Male
2
  28.6%
4
  57.1%
6
  75.0%
12
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 8 participants 22 participants
Hispanic or Latino
5
  71.4%
4
  57.1%
5
  62.5%
14
  63.6%
Not Hispanic or Latino
2
  28.6%
3
  42.9%
3
  37.5%
8
  36.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 8 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
  12.5%
1
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
2
  28.6%
3
  42.9%
2
  25.0%
7
  31.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
  71.4%
4
  57.1%
5
  62.5%
14
  63.6%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 8 participants 22 participants
Has Diabetes
0
   0.0%
2
  28.6%
3
  37.5%
5
  22.7%
No Diabetes
7
 100.0%
5
  71.4%
5
  62.5%
17
  77.3%
1.Primary Outcome
Title Biochemical: Number of Patients With Normal Transaminases at End of Treatment.
Hide Description Biochemical response defined as number of patients with normal transaminases AST <=32 or ALT <=35 U/L at end of treatment.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description:

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Overall Number of Participants Analyzed 7 6 8
Measure Type: Count of Participants
Unit of Measure: Participants
6
  85.7%
6
 100.0%
6
  75.0%
2.Primary Outcome
Title Physiological: Absolute Change in Liver Fat
Hide Description Physiological response defined as absolute change in liver fat measured by 1H-MRS
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description:

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Overall Number of Participants Analyzed 6 6 8
Mean (Standard Deviation)
Unit of Measure: percent liver fat
-1.9  (9.6) -7.6  (3.3) -0.6  (5.2)
3.Secondary Outcome
Title Absolute Change in AST
Hide Description Absolute Change in AST [u/l] by week 24
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description:

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Overall Number of Participants Analyzed 7 6 8
Mean (Standard Deviation)
Unit of Measure: u/l
-5.6  (11.1) -1.8  (4.5) -10.6  (16.7)
4.Secondary Outcome
Title Percent Change in AST
Hide Description Percent change in AST by week 24
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description:

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Overall Number of Participants Analyzed 7 6 8
Mean (Standard Deviation)
Unit of Measure: percent
-0.15  (0.29) -0.07  (0.21) -0.24  (0.4)
5.Secondary Outcome
Title Absolute Change in ALT
Hide Description Absolute Change in ALT [u/l] by week 24
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description:

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Overall Number of Participants Analyzed 7 6 8
Mean (Standard Deviation)
Unit of Measure: u/l
-8  (16.7) -8.3  (10.7) -22  (22)
6.Secondary Outcome
Title Percent Change in ALT
Hide Description Percent change in ALT by week 24
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description:

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Overall Number of Participants Analyzed 7 6 8
Mean (Standard Deviation)
Unit of Measure: percent
-0.17  (0.44) -0.19  (0.23) -0.35  (0.27)
7.Secondary Outcome
Title Absolute Change in GGT
Hide Description Change in GGT by week 24 (U/L)
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description:

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Overall Number of Participants Analyzed 7 5 8
Mean (Standard Deviation)
Unit of Measure: u/l
-6.1  (24.5) -22.8  (50) -11  (18.9)
8.Secondary Outcome
Title Percent Change in Liver Fat
Hide Description Percent change in liver fat by week 24
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description:

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Overall Number of Participants Analyzed 6 6 8
Mean (Standard Deviation)
Unit of Measure: percent of percent liver fat
0.33  (0.93) -0.42  (0.18) -0.10  (0.48)
Time Frame AE data were collected over 144 weeks, from starting treatment to completion of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Hide Arm/Group Description

Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 200 IU/d: Supplement-low dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.

Vitamin E 400 IU/d: Supplement-intermediate dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.

Vitamin E 800 IU/d: Supplement High Dose

Diet and Exercise: Diet and Exercise for all Arms of the study at baseline

All-Cause Mortality
Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/7 (14.29%)   0/7 (0.00%)   3/8 (37.50%) 
Cardiac disorders       
Hypertensive crisis (medication non-compliance) *  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal Bleed *  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Diverticulitis with recto-vaginal fistula *  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Renal and urinary disorders       
Diuretic-induced hypokalemia *  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vit E 200 IU/d Vitamin E 400 Vitamin E 800
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   7/7 (100.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders       
Iron deficiency or anemia *  3/7 (42.86%)  4/7 (57.14%)  4/8 (50.00%) 
Cardiac disorders       
Hypertensive crisis *  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Vasovagal *  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Gastrointestinal disorders       
Diverticulitis *  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Overt gastrointestinal bleeding *  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%) 
Infections and infestations       
Viral gastroenteritis *  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Herpes Keratitis *  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Metabolism and nutrition disorders       
Hypokalemia *  2/7 (28.57%)  0/7 (0.00%)  2/8 (25.00%) 
Musculoskeletal and connective tissue disorders       
Muscle tear *  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Shoulder pain *  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%) 
Jaw swelling *  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Nervous system disorders       
Headache/Migraine *  1/7 (14.29%)  0/7 (0.00%)  1/8 (12.50%) 
Psychiatric disorders       
Depression *  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Anxiety *  0/7 (0.00%)  1/7 (14.29%)  0/8 (0.00%) 
Reproductive system and breast disorders       
Galactorrhea *  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Breast cancer *  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonia *  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Atelectasis (post-anesthesia) *  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Upper respiratory infection *  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders       
Rash *  1/7 (14.29%)  0/7 (0.00%)  0/8 (0.00%) 
Vascular disorders       
Epistaxis *  0/7 (0.00%)  0/7 (0.00%)  2/8 (25.00%) 
Hypertriglyceridemia exacerbation *  0/7 (0.00%)  0/7 (0.00%)  1/8 (12.50%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Yaron Rotman
Organization: NIDDK
Phone: 301-451-6553
EMail: rotmanyaron@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT01792115    
Other Study ID Numbers: 130002
13-DK-0002 ( Other Identifier: NIH Clinical Center )
First Submitted: February 13, 2013
First Posted: February 15, 2013
Results First Submitted: September 21, 2020
Results First Posted: October 19, 2020
Last Update Posted: November 4, 2020