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Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E
Phase 2 trial testing Vitamin E 200 IU/d in Fatty Liver in 22 participants. Completed in 30 August 2019.
| Lead sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 22 |
| Start date | 1 May 2013 |
| Primary completion | 30 August 2019 |
| Estimated completion | 30 August 2019 |
| Sites | 1 location across United States |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
18 and older, any sex, with Fatty Liver. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Biochemical response defined as number of patients with normal transaminases AST \<=32 or ALT \<=35 U/L at end of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Vit E 200 IU/d | 6 | |
| Vitamin E 400 | 6 | |
| Vitamin E 800 | 6 |
Physiological response defined as absolute change in liver fat measured by 1H-MRS
| Group | Value | 95% CI |
|---|---|---|
| Vit E 200 IU/d | -1.9 | ± 9.6 |
| Vitamin E 400 | -7.6 | ± 3.3 |
| Vitamin E 800 | -0.6 | ± 5.2 |
Absolute Change in AST \[u/l\] by week 24
| Group | Value | 95% CI |
|---|---|---|
| Vit E 200 IU/d | -5.6 | ± 11.1 |
| Vitamin E 400 | -1.8 | ± 4.5 |
| Vitamin E 800 | -10.6 | ± 16.7 |
Percent change in AST by week 24
| Group | Value | 95% CI |
|---|---|---|
| Vit E 200 IU/d | -0.15 | ± 0.29 |
| Vitamin E 400 | -0.07 | ± 0.21 |
| Vitamin E 800 | -0.24 | ± 0.4 |
Absolute Change in ALT \[u/l\] by week 24
| Group | Value | 95% CI |
|---|---|---|
| Vit E 200 IU/d | -8 | ± 16.7 |
| Vitamin E 400 | -8.3 | ± 10.7 |
| Vitamin E 800 | -22 | ± 22 |
Percent change in ALT by week 24
| Group | Value | 95% CI |
|---|---|---|
| Vit E 200 IU/d | -0.17 | ± 0.44 |
| Vitamin E 400 | -0.19 | ± 0.23 |
| Vitamin E 800 | -0.35 | ± 0.27 |
Change in GGT by week 24 (U/L)
| Group | Value | 95% CI |
|---|---|---|
| Vit E 200 IU/d | -6.1 | ± 24.5 |
| Vitamin E 400 | -22.8 | ± 50 |
| Vitamin E 800 | -11 | ± 18.9 |
Percent change in liver fat by week 24
| Group | Value | 95% CI |
|---|---|---|
| Vit E 200 IU/d | 0.33 | ± 0.93 |
| Vitamin E 400 | -0.42 | ± 0.18 |
| Vitamin E 800 | -0.10 | ± 0.48 |
Time frame: AE data were collected over 144 weeks, from starting treatment to completion of treatment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Vit E 200 IU/d | Vitamin E 400 | Vitamin E 800 |
|---|---|---|---|---|
| Gastrointestinal Bleed | Gastrointestinal disorders | — | — | — |
| Diuretic-induced hypokalemia | Renal and urinary disorders | — | — | — |
| Diverticulitis with recto-vaginal fistula | Gastrointestinal disorders | — | — | — |
| Hypertensive crisis (medication non-compliance) | Cardiac disorders | — | — | — |
| Reaction | System | Vit E 200 IU/d | Vitamin E 400 | Vitamin E 800 |
|---|---|---|---|---|
| Iron deficiency or anemia | Blood and lymphatic system disorders | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — |
| Shoulder pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Epistaxis | Vascular disorders | — | — | — |
| Overt gastrointestinal bleeding | Gastrointestinal disorders | — | — | — |
| Depression | Psychiatric disorders | — | — | — |
| Headache/Migraine | Nervous system disorders | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — |
| Viral gastroenteritis | Infections and infestations | — | — | — |
| Galactorrhea | Reproductive system and breast disorders | — | — | — |
| Breast cancer | Reproductive system and breast disorders | — | — | — |
| Hypertensive crisis | Cardiac disorders | — | — | — |
| Muscle tear | Musculoskeletal and connective tissue disorders | — | — | — |
| Herpes Keratitis | Infections and infestations | — | — | — |
| Vasovagal | Cardiac disorders | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Atelectasis (post-anesthesia) | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypertriglyceridemia exacerbation | Vascular disorders | — | — | — |
| Jaw swelling | Musculoskeletal and connective tissue disorders | — | — | — |
| Diverticulitis | Gastrointestinal disorders | — | — | — |
Most-reported serious reactions: Gastrointestinal Bleed, Diuretic-induced hypokalemia, Diverticulitis with recto-vaginal fistula, Hypertensive crisis (medication non-compliance).
Data from ClinicalTrials.gov NCT01792115 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing