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WithdrawnNCT04109742Updated Sep 27, 2021

Curcumin for Pediatric Nonalcoholic Fatty Liver Disease

A Phase 2 interventional study of phosphatidylcholine-curcumin complex supplement and Placebo curcumin capsule in NAFLD - Nonalcoholic Fatty Liver Disease and NASH - Nonalcoholic Steatohepatitis, sponsored by Columbia University. Withdrawn. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-09-27.

Sponsored by Columbia University · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Lack of funding
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
8 Years to 17 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

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

Keywords

  • Pediatric
  • NAFLD - nonalcoholic fatty liver disease
  • Curcumin
  • Fatty liver
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

Browse Liver Diseases studies →

Lead sponsor

Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.

Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Curcumin 500mg capsules

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

    Drug: phosphatidylcholine-curcumin complex supplement

  • Active comparator
    Curcumin 1000mg capsules

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

    Drug: phosphatidylcholine-curcumin complex supplement

  • Placebo comparator
    Placebo curcumin capsules

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

    Drug: Placebo curcumin capsule

Interventions

  • Drugphosphatidylcholine-curcumin complex supplement

    a dietary curcumin supplement given at two different doses

    Also known as: Meriva®

  • DrugPlacebo curcumin capsule

    matching placebo to active curcumin capsules

06

What researchers measure

Primary outcomes

  1. Change in serum alanine aminotransferase (ALT) from baseline.

    ALT value in U/L

    Time frame: 24 weeks

Secondary outcomes

  1. Relative change in ALT compared to baseline ALT

    ALT value in U/L

    Time frame: 24 weeks

  2. Proportion of patients achieving normalization of ALT

    ALT value in U/L

    Time frame: 24 weeks

  3. Change in serum aspartate aminotransferase (AST)

    AST value in U/L

    Time frame: 24 weeks

  4. Change in serum gamma-glutamyl transpeptidase (GGT)

    GGT value in U/L

    Time frame: 24 weeks

  5. Change in ALT at 12 weeks compared to baseline ALT

    ALT value in U/L

    Time frame: 12 weeks

  6. Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) compared to baseline

    is an equation which indicates the degree of insulin resistance, where higher scores equate to greater insulin resistance. HOMA-IR is calculated as fasting (Glucose (mmol/L) x insulin (pmol/L))/22.5. A HOMA-IR value \>2.0 in prepubertal children and \>2.6 in pubertal children, may be considered a warning sign for pediatricians to further investigate insulin resistance

    Time frame: 24 weeks

  7. Change in Weight

    kilograms (kg)

    Time frame: 24 weeks

  8. Change in Waist circumference

    centimeters (cm)

    Time frame: 24 weeks

  9. Change in Waist to Hip ratio

    ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement (W ÷ H).

    Time frame: 24 weeks

  10. Change in Body-mass Index Z- Score

    Body mass index z-scores is calculated using age, gender, height and weight and calculated using 2000 CDC Growth Charts for norms.

    Time frame: 24 weeks

  11. Change in serum lipids compared to baseline

    lipid profiles

    Time frame: 24 weeks

  12. Change in High Sensitivity C-Reactive Protein (hsCRP) compared to baseline

    serum marker of inflammation (mg/L)

    Time frame: 24 weeks

  13. Change in Pediatric Quality of Life Inventory (PedsQL) Score scores compared to baseline

    Pediatric Quality of Life Inventory (PedsQL) version 4.0 is completed by both the child and parent/caregiver, and is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales.

    Time frame: 24 weeks

  14. Change in Intrahepatic fat content and liver stiffness

    Hepatic fat content and liver stiffness will be measured by CAP and VCTE (Fibroscan®)

    Time frame: 24 weeks

  15. Change in frequency of adverse events compared to baseline

    Numbers of adverse events reported

    Time frame: 24 weeks

Other outcomes

  1. Plasma concentrations of curcumin and active metabolites from baseline to 24 weeks.

    Pharmacokinetic analysis

    Time frame: Day 0 pre-dose and 1, 2, 4, 6, 8 hours post-dose; Day 14; Day 28; Day 84 and Day 168

  2. Change in interleukin 6 (IL-6)

    cytokine protein involved in the pro-inflammatory and anti-inflammatory response

    Time frame: 24 weeks

  3. Change in interleukin 8 (IL-8)

    cytokine protein involved in the pro-inflammatory and anti-inflammatory response

    Time frame: 24 weeks

  4. Change in (TNF-a) Tumor Necrosis Factor alpha

    cytokine protein involved in the pro-inflammatory and anti-inflammatory response

    Time frame: 24 weeks

  5. Change in Plasminogen Activator Inhibitor (PAI-1)

    cytokine protein involved in the pro-inflammatory and anti-inflammatory response

    Time frame: 24 weeks

  6. Change in adiponectin

    cytokine protein involved in the pro-inflammatory and anti-inflammatory response

    Time frame: 24 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04109742
Lead sponsor
Columbia University
Collaborators
Thorne HealthTech, Inc
Responsible party
Sponsor
First posted
Sep 30, 2019
Start date
Dec 9, 2019
Primary completion
Apr 22, 2020
Completion
Apr 22, 2020
Last update
Sep 27, 2021

Study contacts

Joel E Lavine, MD, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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