NAFLD - Nonalcoholic Fatty Liver DiseasePhase 2NCT04109742
Curcumin for Pediatric Nonalcoholic Fatty Liver Disease
A Phase 2 study testing phosphatidylcholine-curcumin complex supplement in people with NAFLD - Nonalcoholic Fatty Liver Disease and NASH - Nonalcoholic Steatohepatitis, run by Columbia University.
Trial 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 more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- NAFLD - Nonalcoholic Fatty Liver Disease, NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- phosphatidylcholine-curcumin complex supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2019to 22 Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
About this study
Official title: Curcumin for Pediatric Nonalcoholic Fatty Liver Disease: A Pilot Randomized Controlled Trial
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.
- Being tested
- phosphatidylcholine-curcumin complex supplement, Placebo curcumin capsule
- Keywords
- Pediatric, NAFLD - nonalcoholic fatty liver disease, Curcumin, Fatty liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phosphatidylcholine-curcumin complex supplementDrug
Also called Meriva®
a dietary curcumin supplement given at two different doses
Placebo curcumin capsuleDrug
matching placebo to active curcumin capsules
| Study group | Role | What they receive |
|---|---|---|
| Curcumin 500mg capsules | Active comparator | Dose will be 500mg daily phosphatidylcholine-curcumin complex supplement, orally for 24 weeks Receives: Drug: phosphatidylcholine-curcumin complex supplement |
| Curcumin 1000mg capsules | Active comparator | Dose will be1g daily of phosphatidylcholine-curcumin complex supplement, orally for 24 weeks Receives: Drug: phosphatidylcholine-curcumin complex supplement |
| Placebo curcumin capsules | Placebo comparator | Dose will be matching placebo capsules daily, orally for 24 weeks Receives: Drug: Placebo curcumin capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum alanine aminotransferase (ALT) from baseline.
ALT value in U/L
Measured: 24 weeks
Secondary outcomes (15)
Relative change in ALT compared to baseline ALT
ALT value in U/L
Measured: 24 weeks
Proportion of patients achieving normalization of ALT
ALT value in U/L
Measured: 24 weeks
Change in serum aspartate aminotransferase (AST)
AST value in U/L
Measured: 24 weeks
Change in serum gamma-glutamyl transpeptidase (GGT)
GGT value in U/L
Measured: 24 weeks
Change in ALT at 12 weeks compared to baseline ALT
ALT value in U/L
Measured: 12 weeks
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
Measured: 24 weeks
Change in Weight
kilograms (kg)
Measured: 24 weeks
Change in Waist circumference
centimeters (cm)
Measured: 24 weeks
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).
Measured: 24 weeks
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.
Measured: 24 weeks
Change in serum lipids compared to baseline
lipid profiles
Measured: 24 weeks
Change in High Sensitivity C-Reactive Protein (hsCRP) compared to baseline
serum marker of inflammation (mg/L)
Measured: 24 weeks
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.
Measured: 24 weeks
Change in Intrahepatic fat content and liver stiffness
Hepatic fat content and liver stiffness will be measured by CAP and VCTE (Fibroscan®)
Measured: 24 weeks
Change in frequency of adverse events compared to baseline
Numbers of adverse events reported
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start9 Dec 2019
- Primary completion22 Apr 2020
- Study completion22 Apr 2020
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD - Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The comparison of two different doses (500mg/qd and 1g/qd) of a phosphatidylcholine-curcumin complex supplement, to matching placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Thorne HealthTech, Inc
- Responsible party
- Sponsor
- Investigators
- Joel E Lavine, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109742
- Sponsor's protocol ID
- AAAS6731
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2019
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin for Pediatric Nonalcoholic Fatty Liver Disease: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04109742
- Acronym / sponsor ID
- AAAS6731
- Keywords
- Pediatric, NAFLD - nonalcoholic fatty liver disease, Curcumin, Fatty liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Thorne HealthTech, Inc
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- The comparison of two different doses (500mg/qd and 1g/qd) of a phosphatidylcholine-curcumin complex supplement, to matching placebo
| Arm | Type | Receives |
|---|---|---|
| Curcumin 500mg capsules | Active comparator | Drug: phosphatidylcholine-curcumin complex supplementDose will be 500mg daily phosphatidylcholine-curcumin complex supplement, orally for 24 weeks |
| Curcumin 1000mg capsules | Active comparator | Drug: phosphatidylcholine-curcumin complex supplementDose will be1g daily of phosphatidylcholine-curcumin complex supplement, orally for 24 weeks |
| Placebo curcumin capsules | Placebo comparator | Drug: Placebo curcumin capsuleDose will be matching placebo capsules daily, orally for 24 weeks |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phosphatidylcholine-curcumin complex supplementAlso: Meriva®a dietary curcumin supplement given at two different doses | Drug | Curcumin 1000mg capsules, Curcumin 500mg capsules |
| Placebo curcumin capsulematching placebo to active curcumin capsules | Drug | Placebo curcumin capsules |
Primary outcome
Change in serum alanine aminotransferase (ALT) from baseline.
Time frame: 24 weeks
ALT value in U/L
15 secondary outcomes
Relative change in ALT compared to baseline ALT
Time frame: 24 weeks
Proportion of patients achieving normalization of ALT
Time frame: 24 weeks
Change in serum aspartate aminotransferase (AST)
Time frame: 24 weeks
Change in serum gamma-glutamyl transpeptidase (GGT)
Time frame: 24 weeks
Change in ALT at 12 weeks compared to baseline ALT
Time frame: 12 weeks
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) compared to baseline
Time frame: 24 weeks
Change in Weight
Time frame: 24 weeks
Change in Waist circumference
Time frame: 24 weeks
Change in Waist to Hip ratio
Time frame: 24 weeks
Change in Body-mass Index Z- Score
Time frame: 24 weeks
Change in serum lipids compared to baseline
Time frame: 24 weeks
Change in High Sensitivity C-Reactive Protein (hsCRP) compared to baseline
Time frame: 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) Score scores compared to baseline
Time frame: 24 weeks
Change in Intrahepatic fat content and liver stiffness
Time frame: 24 weeks
Change in frequency of adverse events compared to baseline
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel E Lavine, MD, PhD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing phosphatidylcholine-curcumin complex supplement in people with NAFLD - Nonalcoholic Fatty Liver Disease and NASH - Nonalcoholic Steatohepatitis, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum alanine aminotransferase (ALT) from baseline. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.