Curcumin for Pediatric Nonalcoholic Fatty Liver Disease

NCT04109742 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: AAAS6731
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

NAFLD - Nonalcoholic Fatty Liver Disease; NASH - Nonalcoholic Steatohepatitis

Keywords

Pediatric; NAFLD - nonalcoholic fatty liver disease; Curcumin; Fatty liver

Outcome Measures

Primary Outcomes (1)

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

  ALT value in U/L

  24 weeks

Secondary Outcomes (15)

• Relative change in ALT compared to baseline ALT

  24 weeks

• Proportion of patients achieving normalization of ALT

  24 weeks

• Change in serum aspartate aminotransferase (AST)

  24 weeks

• Change in serum gamma-glutamyl transpeptidase (GGT)

  24 weeks

• Change in ALT at 12 weeks compared to baseline ALT

  12 weeks

Other Outcomes (6)

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

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

• Change in interleukin 6 (IL-6)

  24 weeks

• Change in interleukin 8 (IL-8)

  24 weeks

Study Arms (3)

Curcumin 500mg capsules

ACTIVE COMPARATOR

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

Drug: phosphatidylcholine-curcumin complex supplement

Curcumin 1000mg capsules

ACTIVE COMPARATOR

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

Drug: phosphatidylcholine-curcumin complex supplement

Placebo curcumin capsules

PLACEBO COMPARATOR

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

Drug: Placebo curcumin capsule

Interventions

phosphatidylcholine-curcumin complex supplement DRUG

a dietary curcumin supplement given at two different doses

Also known as: Meriva®

Curcumin 1000mg capsules; Curcumin 500mg capsules

Placebo curcumin capsule DRUG

matching placebo to active curcumin capsules

Placebo curcumin capsules

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Thorne HealthTech, Inc: collaborator

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Joel E Lavine, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, investigators, clinical staff, and data monitoring committee will not have knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The comparison of two different doses (500mg/qd and 1g/qd) of a phosphatidylcholine-curcumin complex supplement, to matching placebo

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 30, 2019
• Study Start: December 9, 2019
• Primary Completion: April 22, 2020
• Study Completion: April 22, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share