Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E
Status:
Completed
Trial end date:
2019-08-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
alpha-Tocopherol Tocopherols Tocotrienols Vitamin E Vitamins