Status:
WITHDRAWN
Curcumin for Pediatric Nonalcoholic Fatty Liver Disease
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Thorne HealthTech, Inc
Conditions:
NAFLD - Nonalcoholic Fatty Liver Disease
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
8-17 years
Phase:
PHASE2
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 participant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04109742
Start Date
December 9 2019
End Date
April 22 2020
Last Update
September 27 2021
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