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Curcumin for Pediatric Nonalcoholic Fatty Liver Disease

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:
Curcumin for Pediatric Nonalcoholic Fatty Liver Disease: A Pilot Randomized Controlled Trial

Clinical Trial Summary

This is a single-center, randomized, double-blinded, placebo-controlled, parallel treatment groups phase 2a study of curcumin for pediatric nonalcoholic fatty liver disease (NAFLD).

Clinical Trial Description

30 subjects ages 8-17y, with biopsy-proven NASH/NAFLD (≤ 730 days prior to registration and a NAFLD Activity Score (NAS) of ≥3) and serum ALT at screening ≥ 50 IU/L at enrollment. Eligible participants will receive curcumin 500 mg, 1.0 g or placebo for 24 weeks, randomized 1:1:1. The primary outcome of the study will determine whether 24 weeks of curcumin supplementation compared to matching placebo improves measures of nonalcoholic fatty liver disease (NAFLD) as determined by relative improvement in serum ALT from baseline. The hypothesis is that curcumin will significantly decrease ALT relative to placebo in children with NAFLD. ;

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • Liver Diseases
  • NAFLD - Nonalcoholic Fatty Liver Disease
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
Clinical Trial Details
NCT number NCT04109742
Study type Interventional
Source Columbia University
Contact
Status Withdrawn
Phase Phase 2
Start date December 9, 2019
Completion date April 22, 2020
View Details
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