Curcumin for Pediatric Nonalcoholic Fatty Liver Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- NAFLD - Nonalcoholic Fatty Liver Disease
- NASH - Nonalcoholic Steatohepatitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The comparison of two different doses (500mg/qd and 1g/qd) of a phosphatidylcholine-curcumin complex supplement, to matching placeboMasking: Triple (Participant, Care Provider, Investigator)Masking Description: Participants, investigators, clinical staff, and data monitoring committee will not have knowledge of the interventions assigned to individual participants.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 8 years and 17 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04109742
- Collaborators
- Thorne Research Inc.
- Investigators
- Principal Investigator: Joel E Lavine, MD, PhD Columbia University
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