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NCT01792115 · ClinicalTrials.gov registry record · Phase 2
Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT01792115 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 22 participants.
The verdict
NCT01792115, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study 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 pil
Interventions
- BEHAVIORAL Diet and Exercise
- DRUG Vitamin E 200 IU/d
- DRUG Vitamin E 400 IU/d
- DRUG Vitamin E 800 IU/d
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-05-01 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01792115
The ClinicalTrials.gov registry entry for NCT01792115 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Diet and Exercise is the first listed.
NCT01792115 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01792115 about?
NCT01792115 is a clinical study titled "Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E". 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 o...
What is the current status of trial NCT01792115?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2013-05-01. Estimated completion is 2019-08-30.
What interventions are being tested in trial NCT01792115?
The interventions under investigation include: Diet and Exercise (BEHAVIORAL), Vitamin E 200 IU/d (DRUG), Vitamin E 400 IU/d (DRUG), Vitamin E 800 IU/d (DRUG).
Who is sponsoring clinical trial NCT01792115?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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