Curcumin for Pediatric Nonalcoholic Fatty Liver Disease

NCT ID: NCT04109742

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2020-04-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Curcumin 500mg capsules

Dose will be 500mg daily phosphatidylcholine-curcumin complex supplement, orally for 24 weeks

Group Type: ACTIVE_COMPARATOR

phosphatidylcholine-curcumin complex supplement

Intervention Type: DRUG

a dietary curcumin supplement given at two different doses

Curcumin 1000mg capsules

Dose will be1g daily of phosphatidylcholine-curcumin complex supplement, orally for 24 weeks

Group Type: ACTIVE_COMPARATOR

phosphatidylcholine-curcumin complex supplement

Intervention Type: DRUG

a dietary curcumin supplement given at two different doses

Placebo curcumin capsules

Dose will be matching placebo capsules daily, orally for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo curcumin capsule

Intervention Type: DRUG

matching placebo to active curcumin capsules

Interventions

phosphatidylcholine-curcumin complex supplement

a dietary curcumin supplement given at two different doses

Intervention Type: DRUG

Placebo curcumin capsule

matching placebo to active curcumin capsules

Intervention Type: DRUG

Other Intervention Names

Meriva®

Eligibility Criteria

Inclusion Criteria

• Age 8-17 years at initial screening interview
• Histological evidence of NAFLD with or without fibrosis and a NAFLD activity score (NAS) of ≥3, on a liver biopsy obtained no more than 730 days prior to enrollment
• Serum ALT at screening ≥ 50 IU/L

Exclusion Criteria

• Significant alcohol consumption or inability to reliably quantify alcohol intake
• Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 consecutive weeks in the past year prior to randomization
• New treatment with vitamin E or metformin started in the past 90 days or plans to alter the dose or stop over the next the 24 weeks. A stable dose is acceptable.
• Prior or planned bariatric surgery
• Uncontrolled diabetes (HbA1c 9.5% or higher within 30 days prior to enrollment)
• Presence of cirrhosis on liver biopsy
• Stage 2 Hypertension or >140 systolic or >90 diastolic at screening
• Current daily use of nonsteroidal anti-inflammatory drugs (NSAIDs)
• Platelet counts below 100,000 /mm3
• Clinical evidence of hepatic decompensation (serum albumin < 3.2 g/dL, international normalized ratio (INR) >1.3, direct bilirubin >1.3 mg/dL, history of esophageal varices, ascites, or hepatic encephalopathy)
• Evidence of chronic liver disease other than NAFLD:

• Biopsy consistent with histological evidence of autoimmune hepatitis
• Serum hepatitis B surface antigen (HBsAg) positive.
• Serum hepatitis C antibody (anti-HCV) positive.
• Iron/total iron binding capacity (TIBC) ratio (transferrin saturation) > 45% with histological evidence of iron overload
• Alpha-1-antitrypsin (A1AT) phenotype/genotype ZZ or SZ
• Wilson's disease
• History of biliary diversion
• History of kidney disease and/or estimated glomerular filtration rate (eGFR) < than 60 mL/min/1.73 m2 using Schwartz Bedside GFR Calculator for Children isotope dilution mass spectroscopy (IDMS)-traceable
• Known Human Immunodeficiency Virus (HIV) infection
• Active, serious medical disease with life expectancy less than 5 years
• Active substance abuse including inhaled or injected drugs, in the year prior to screening
• Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding
• Participation in any clinical/investigational trial within the prior 150 days and during the study.
• Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study
• Inability to swallow capsules
• Known allergy to curcumin or any of its components
• Failure of parent or legal guardian to give informed consent or subject to give informed assent

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thorne HealthTech, Inc

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel E Lavine, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Other Identifiers

AAAS6731

Identifier Type: -

Identifier Source: org_study_id