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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: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Biochemical response defined as number of patients with normal transaminases AST \<=32 or ALT \<=35 U/L at end of treatment.
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 |
What the finished NCT01792115 record still lists
NCT01792115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 4 interventions - of which Diet and Exercise is the first listed.
NCT01792115 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01792115's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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