CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Vitamin E 200 IU/d +3 moredrug
Likely dose
Vitamin E 200 IU/dfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01792115
NCT01792115Phase 2Completed

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Feb 15, 2013·Updated Nov 4, 2020

In Brief

A Phase 2 clinical trial evaluating Vitamin E 200 IU/d, Vitamin E 400 IU/d, and 2 other interventions for Fatty Liver. Completed, enrolled 22 participants across 1 site.

Detailed Summary

Background: * Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver cells. It is associated with obesity, high blood pressure, high cholesterol, and diabetes. Some people with NAFLD only have excess fat in the liver. However, other people may develop a worse form of NAFLD with liver injury and scarring. This form, called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer, and death. Not much is known about why some people develop NASH and others do not. * Lifestyle changes such as diet, exercise, and weight loss can decrease the liver damage in NAFLD. Some studies show that vitamin E can also help treat NAFLD. The dose of vitamin E used in these studies is almost 40 times the recommended amount of vitamin E intake from food. It is unclear whether a lower dose could achieve the same effect. Researchers also want to study how vitamin E works at different doses to treat NAFLD. Objectives: * To find out the most effective dose of vitamin E to treat NAFLD. * To gain a better understanding of how NAFLD and NASH develop, and predict who will respond to treatment. Eligibility: \- Individuals at least 18 years of age with suggestion of non-alcoholic fatty liver disease. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * For the first 12 weeks of the study, participants will meet with a nutritionist. They will have personalized diet and exercise plans. Treatment will be monitored with diaries and questionnaires to fill out at home. Participants will also wear a pedometer to measure physical activity. * After the 12-week period, participants will have a full physical examination with the following tests: * Blood tests * Glucose tolerance tests * Imaging studies (DEXA scan and magnetic resonance imaging) * Liver and fatty tissue biopsy * Two weeks after the tests, participants will start vitamin E treatment. They will take up to two pills a day, taken with fat-containing foods. * 4 weeks after starting treatment they will have a repeat full evaluation with imaging tests, blood work, and liver and fat biopsies. * Participants who are taking vitamin E will take it for up to 120 weeks. They will have monitoring visits every 8 to 12 weeks. At the end of 120 weeks, they will have another full evaluation, with imaging tests, blood work, and liver and fat biopsies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatty Liver
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2013
Enrollment StartMay 1, 2013
Primary CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 13.4 years ago

Interventions

Vitamin E 200 IU/ddrug

Supplement-low dose

Vitamin E 400 IU/ddrug

Supplement-intermediate dose

Vitamin E 800 IU/ddrug

Supplement High Dose

Diet and Exercisebehavioral

Diet and Exercise for all Arms of the study at baseline