Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E
Brief 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.


Options:
A: Arm Label: Arm 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: pioglitazone-placebo, Drug: Vitamin E-placebo | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: pioglitazone, Dietary Supplement: Vitamin E | Arm Label: Arm 3; Type: OTHER; Interventions: Drug: pioglitazone-placebo, Dietary Supplement: Vitamin E | Intervention Type: DRUG; Name: pioglitazone-placebo; Assigned to Arm(s): Arm 1 | Intervention Type: DRUG; Name: pioglitazone; Assigned to Arm(s): Arm 2 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Arm 2 | Intervention Type: DRUG; Name: pioglitazone-placebo; Assigned to Arm(s): Arm 3 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin E; Assigned to Arm(s): Arm 3 | Intervention Type: DRUG; Name: Vitamin E-placebo; Assigned to Arm(s): Arm 1
B: Arm Label: Ginseng trial; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Red ginseng | Intervention Type: DIETARY_SUPPLEMENT; Name: Red ginseng; Assigned to Arm(s): Ginseng trial
C: Arm Label: Vit E 200 IU/d; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 200 IU/d, Behavioral: Diet and Exercise | Arm Label: Vitamin E 400; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 400 IU/d, Behavioral: Diet and Exercise | Arm Label: Vitamin E 800; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin E 800 IU/d, Behavioral: Diet and Exercise | Intervention Type: DRUG; Name: Vitamin E 200 IU/d; Assigned to Arm(s): Vit E 200 IU/d | Intervention Type: DRUG; Name: Vitamin E 400 IU/d; Assigned to Arm(s): Vitamin E 400 | Intervention Type: DRUG; Name: Vitamin E 800 IU/d; Assigned to Arm(s): Vitamin E 800 | Intervention Type: BEHAVIORAL; Name: Diet and Exercise; Assigned to Arm(s): Vit E 200 IU/d, Vitamin E 400, Vitamin E 800
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Omega-3 carboxylic acids 4g / day; Type: EXPERIMENTAL; Interventions: Drug: Omega-3 carboxylic acid | Arm Label: Fenofibrate 200mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fenofibrate 200mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Omega-3 carboxylic acid; Assigned to Arm(s): Omega-3 carboxylic acids 4g / day | Intervention Type: DRUG; Name: Fenofibrate 200mg; Assigned to Arm(s): Fenofibrate 200mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C