| Trial ID: | L0723 |
| Source ID: | NCT04198805
|
| Associated Drug: |
Vitamin E
|
| Title: |
The Effect of Vitamin E and Docosahexaenoic Acid Ethyl Ester on Non-Alcoholic Fatty Liver Disease (NAFLD) - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)
|
| Acronym: |
PUVENAFLD
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease;Non-Alcoholic Fatty Liver;Non-Alcoholic Steatohepatitis
|
| Interventions: |
Dietary Supplement: Vitamin E [(all-rac)-a-tocopheryl acetate];Dietary Supplement: Omega-3 fatty acid (DHA EE);Combination Product: Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-a-tocopheryl acetate];Other: Placebo
|
| Outcome Measures: |
Decrease in hepatic fat fraction [%] between Vitamin E + DHA combination vs placebo armDecrease in hepatic fat fraction [%] between Vitamin E vs placebo arm;Decrease in hepatic fat fraction [%] between DHA EE vs placebo arm;Change after 6 months of DHA EE and/ or Vitamin E intervention in the anthropometric measure, waist circumference.;Change after 6 months of DHA EE and/ or Vitamin E intervention in the anthropometric measure, bodyweight.;Change after 6 months of DHA EE and/ or Vitamin E intervention in the anthropometric measure, waist-to-hip ratio.;Change after 6 months of DHA EE and/ or Vitamin E intervention in the anthropometric measure, body mass index (BMI);Insulin resistance;Liver enzymes (ALT, AST, Albumin, Bilirubin, GGT, Alkaline Phosphatase and Creatinine);Fibrosis-4 (FIB-4) score;Plasma Vitamin E concentration;Plasma DHA EE concentration;Lipid profile (e.g. HDL-C, low density lipoprotein (LDL-C), TGs, oxidized LDL);Health related quality of life score (Short form (SF-36));Dietary Intake Levels of LC-PUFA (i.e. DHA and EPA) as measured by the Food Frequency Questionnaire (FFQ);Inflammatory markers (e.g. cytokeratin 18 (CK-18), TNFa, IL-1??)
|
| Sponsor/Collaborators: |
Naga P. Chalasani
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 2
|
| Enrollment: |
200
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
30/10/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 January 2022
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04198805
|
