NCT04109742

Curcumin for Pediatric Nonalcoholic Fatty Liver Disease

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• NAFLD - Nonalcoholic Fatty Liver Disease
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	phosphatidylcholine-curcumin complex supplement	a dietary curcumin supplement given at two different doses
DRUG	Placebo curcumin capsule	matching placebo to active curcumin capsules

Timeline

• Start date: 2019-12-09
• Primary completion: 2020-04-22
• Completion: 2020-04-22
• First posted: 2019-09-30
• Last updated: 2021-09-27

Regulatory

• FDA-regulated drug study