| Trial ID: | L0033 |
| Source ID: | NCT04109742
|
| Associated Drug: |
Curcumin
|
| Title: |
Curcumin for Pediatric Nonalcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Withdrawn
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NAFLD - Nonalcoholic Fatty Liver Disease|NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: phosphatidylcholine-curcumin complex supplement|Drug: Placebo curcumin capsule
|
| Outcome Measures: |
Change in serum alanine aminotransferase (ALT) from baseline.|Relative change in ALT compared to baseline ALT|Proportion of patients achieving normalization of ALT|Change in serum aspartate aminotransferase (AST)|Change in serum gamma-glutamyl transpeptidase (GGT)|Change in ALT at 12 weeks compared to baseline ALT|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) compared to baseline|Change in Weight|Change in Waist circumference|Change in Waist to Hip ratio|Change in Body-mass Index Z- Score|Change in serum lipids compared to baseline|Change in High Sensitivity C-Reactive Protein (hsCRP) compared to baseline|Change in Pediatric Quality of Life Inventory (PedsQL) Score scores compared to baseline|Change in Intrahepatic fat content and liver stiffness|Change in frequency of adverse events compared to baseline
|
| Sponsor/Collaborators: |
Columbia University|Thorne Research Inc.
|
| Gender: |
All
|
| Age: |
8 Years to 17 Years ?? (Child)
|
| Phases: |
Phase 2
|
| Enrollment: |
0
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
December 9, 2019
|
| Completion Date: |
April 22, 2020
|
| Results First Posted: |
--
|
| Last Update Posted: |
September 27, 2021
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT04109742
|
