Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 706 for:    tocotrienols

Tocotrienol Against the Progression of End Stage Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02581085
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
Malaysia Palm Oil Board
Information provided by (Responsible Party):
Raj Vuppalanchi, Indiana University

Tracking Information
First Submitted Date  ICMJE June 26, 2015
First Posted Date  ICMJE October 20, 2015
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2019)
Effect of Oral tocotrienols (TCT) on Model for End-Stage Liver Disease (MELD) score. [ Time Frame: 3 years ]
Lab tests to calculate MELD score will be taken at baseline study visit and the last study visit ( Study visit 8 - 3 years) to see if Oral TCT will significantly attenuate the rise in MELD score over time in patients with End Stage Liver Disease / Cirrhosis
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2015)
Effect of Oral tocotrienols (TCT) on Model for End-Stage Liver Disease (MELD) score [ Time Frame: 3 years ]
Lab tests including viral load viral, viral genotype, bilirubmin, fibrosure, and INR will be taken at baseline study visit and the last study visit ( Study visit 8 - 3 years) and will calculate MELD scores to see if Oral TCT will significantly attenuate the rise in MELD score over time in patients with hepatitis C cirrhosis.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tocotrienol Against the Progression of End Stage Liver Disease
Official Title  ICMJE Tocotrienol Against the Progression of End Stage Liver Disease
Brief Summary The purpose of this Phase 2 trial is to validate the outcome observed in a previous trial that oral Tocotrienol (TCT) attenuates the rise in MELD score over time in patients with end stage liver disease / cirrhosis. The study is double blind and participants will be randomized to take 2 capsules of TCT (200mg) or placebo twice a day for 3 years.
Detailed Description

Tocotrienol (TCT) is a natural vitamin E supplement with a long history of safe dietary consumption. Prior studies with Vitamin E have shown beneficial effects in patients with non-alcoholic fatty liver disease and cirrhosis. The primary purpose of this Phase 2 trial is to validate the outcome observed in an earlier trial that oral TCT attenuates the rise in MELD (Model For End-Stage Liver Disease) score over time in patients with cirrhosis. Outcomes of this trail will direct the design of a future larger multi-center trial.

Study participation will last 3 years. Subjects will be seen for an initial visit, at which consent will be obtained and baseline labs drawn, followed by a Randomization visit 2-14 days later after MELD criteria have been confirmed. If the acceptable labs have not been drawn per standard of care to calculate a MELD score within 90 days before the initial visit, the subject will complete the initial visit as planned, but will then return for a repeat lab draw 60 days later to confirm MELD criteria for eligibility before continuing to the randomization visit.

Enrollment occurs when a subject meets all criteria and is randomized into one of the treatment groups. Subjects will then be seen in the research office by research personnel at 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 18 months, 2 years, and 3 years. Subject compliance with supplements will be closely followed, as compliance is critical for accurate data. Given the small sample size, subjects who are less than 75% compliant at two consecutive study visits will be discontinued from the study. Subjects will be discontinued if their MELD score increases by more than 25% between 2 consecutive visits or if they receive an organ transplant. Subjects will be declared lost to follow-up (LTFU) if a study visit is unable to be scheduled and completed after 4 documented attempts to contact a subject with no response. In this circumstance, a certified letter will be mailed to the subject's last known address; if no response is received, the subject is LTFU. All subjects discontinued or LTFU before the end of 1 year of study participation will be replaced (see protocol to review study visit activities that will occur). At the Randomization Visit, enrolled subjects will be randomized into one of two treatment groups in a 1:1 manner. Group 1: Placebo vehicle; (2) placebo capsules following AM meal, (2) placebo capsules following PM meal Group 2: 800mg TCT; (2) 200mg TCT capsules following AM meal, (2) 200mg TCT capsules following PM meal.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Condition  ICMJE
  • End Stage Liver Disease
  • NASH - Nonalcoholic Steatohepatitis
  • NAFLD - Nonalcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: Tocotrienol (TCT)
    TCT is a natural vitamin E supplement with a long history of safe dietary consumption in humans. The objective of the current trial is to validate the outcome observed in an earlier trial that oral TCT attenuates the rise in MELD score over time in patients with end stage liver disease/cirrhosis.
  • Other: Placebo
    Control study capsule that includes no study product (Vitamin E - Tocotrienol)
    Other Name: vehicle
Study Arms  ICMJE
  • Placebo Comparator: Placebo Vehicle
    Subjects will take 2 placebo capsules following AM meal, 2 placebo capsules following PM capsules
    Intervention: Other: Placebo
  • Active Comparator: Tocotrienol supplement
    Subjects will take (2) 200 mg TCT capsules following AM meal, (2) 200 mg TCT following PM meal
    Intervention: Drug: Tocotrienol (TCT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2015)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2028
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years of above, male or female
  • ESLD patients with clinically- diagnosed NAFLD or NASH
  • Absence of any other possible cause for liver dysfunction
  • Stable MELD score of at least 8, but no greater than 15 over the past 6 months (+/- 1 month) prior to enrollment
  • Able to speak and understand English
  • Willing and able to provide informed consent
  • Willing and able to return for regularly scheduled research study visits & comply with study requirements

Exclusion Criteria:

  • Rapid deterioration of liver function, over the past 6 months (+/- 1 month) prior to enrollment per study physician determination
  • Hepatocellular carcinoma
  • Positive HIV/ AIDS, or other chronic immunodeficiency
  • Concurrent hepatitis A or B infection
  • Current drug and/or alcohol abuse (per treating physician)
  • Bacterial infection at time of enrollment
  • Daily use of dedicated vitamin E supplementation within the 12 months prior to study participation
  • Platelets <25,000 cells/µL, neutrophils <1000 cells/µL, hemoglobin <8g/dL, total bilirubin >3mg/dL, serum creatinine >2.0mg/dL
  • Women who are pregnant, breastfeeding, or plan to become pregnant during course of study participation (36 months)
  • Other significant comorbidities which limit the subject's life expectancy to less than 36 months
  • Patients receiving medications known to treat Hepatitis C; patients who begin taking these medications during the course of study participation will be dropped.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Mohnacky, RN 317-278-2715 jmohnack@iu.edu
Contact: Sashwati Roy, Ph.D 3172782706 roysa@iu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02581085
Other Study ID Numbers  ICMJE 1807361301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raj Vuppalanchi, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Malaysia Palm Oil Board
Investigators  ICMJE
Study Chair: Chandan K Sen, Ph.D Indiana University School of Medicine
Principal Investigator: Raj Vuppalanchi, M.D. Indiana Unviersity School of Medicine
PRS Account Indiana University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP