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Trial record 4 of 712 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

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.

Condition or disease Intervention/treatment Phase
End Stage Liver Disease NASH - Nonalcoholic Steatohepatitis NAFLD - Nonalcoholic Fatty Liver Disease Drug: Tocotrienol (TCT) Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Tocotrienol Against the Progression of End Stage Liver Disease
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2028


Arm Intervention/treatment
Placebo Comparator: Placebo Vehicle
Subjects will take 2 placebo capsules following AM meal, 2 placebo capsules following PM capsules
Other: Placebo
Control study capsule that includes no study product (Vitamin E - Tocotrienol)
Other Name: vehicle

Active Comparator: Tocotrienol supplement
Subjects will take (2) 200 mg TCT capsules following AM meal, (2) 200 mg TCT following PM meal
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581085


Contacts
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Contact: Jennifer Mohnacky, RN 317-278-2715 jmohnack@iu.edu
Contact: Sashwati Roy, Ph.D 3172782706 roysa@iu.edu

Locations
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United States, Indiana
IU Health Unviersity Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Heather Adams, RN    317-962-1130    hejadams@iu.edu   
Contact: Jessie Vaughn, RN    317-274-8427    jevaughn@iu.edu   
Sponsors and Collaborators
Indiana University
Malaysia Palm Oil Board
Investigators
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Study Chair: Chandan K Sen, Ph.D Indiana University School of Medicine
Principal Investigator: Raj Vuppalanchi, M.D. Indiana Unviersity School of Medicine
Publications:

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Responsible Party: Raj Vuppalanchi, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT02581085    
Other Study ID Numbers: 1807361301
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raj Vuppalanchi, Indiana University:
Tocotrienol
Vitamin E
Additional relevant MeSH terms:
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Tocotrienols
Vitamin E
Tocopherols
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances