Clinical Trial Details
| Trial ID: | L0097 |
| Source ID: | NCT04801849 |
| Associated Drug: | Vitamin E |
| Title: | Vitamin E Dosing Study |
| Acronym: | VEDS |
| Status: | Not yet recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Nonalcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis |
| Interventions: | Drug: d-alpha-tocopherol|Drug: Placebo |
| Outcome Measures: | Relative change in alanine aminotransferase (ALT) from baseline to 24 weeks|Proportion of patients achieving normalization of alanine aminotransferase (ALT) at 24 weeks|Mean change in serum alanine aminotransferase (ALT) from baseline|Mean change in serum aspartate aminotransferase (AST) from baseline|Mean change in hepatic steatosis (fat in the liver) score determined by Fibroscan?? Controlled Attenuation Parameter (CAP) software function|Mean change in liver stiffness from baseline assessed by Fibroscan?? |
| Sponsor/Collaborators: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|Duke University|Liver Institute Northwest|Indiana University|St. Louis University|University of California, San Diego|University of Southern California|University of California, San |
| Gender: | All |
| Age: | 18 Years and older ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 200 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment |
| Start Date: | March 2022 |
| Completion Date: | May 2024 |
| Results First Posted: | -- |
| Last Update Posted: | February 14, 2022 |
| Locations: | University of California, San Diego, La Jolla, California, United States|University of Southern California, Los Angeles, California, United States|University of California, San Francisco, San Francisco, California, United States|Indiana University- Adults, Indianapolis, Indiana, United States|St. Louis University, Saint Louis, Missouri, United States|Duke University Medical Center, Durham, North Carolina, United States|Cleveland Clinic Foundation, Cleveland, Ohio, United States|Virginia Commonwealth University, Richmond, Virginia, United States|Liver Institute Northwest, Seattle, Washington, United States |
| URL: | https://ClinicalTrials.gov/show/NCT04801849 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D388 | Vitamin E | Supplement | DB00163 | NR1I2; ALOX5; DGKA | Anti-inflammatory | Under clinical trials | Details |
| D008 | Alpha-tocopherol | Chemical drug | DB00163 | NR1I2; ALOX5; DGKA | -- | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D199 | L-alanine | Chemical drug | DB00160 | KYNU | -- | Failed in clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |