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Vitamin E Derivative
Tocotrienol for End Stage Liver Disease
Phase 2
Recruiting
Led By Raj Vuppalanchi, M.D.
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ESLD patients with clinically-diagnosed NAFLD or NASH
Absence of any other possible cause for liver dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is to see if a previous trial's results were accurate- that Tocotrienol (TCT) could help end stage liver disease / cirrhosis patients by taking 2 capsules of it (200mg) or placebo twice a day for 3 years.
Who is the study for?
Adults with end stage liver disease or cirrhosis, specifically from non-alcoholic fatty liver disease (NAFLD) or NASH, who have a stable MELD score between 8 and 17. Participants must not have other causes for liver dysfunction, no hepatitis B/C or HIV/AIDS, no recent rapid deterioration of liver function, and cannot be pregnant or planning pregnancy.Check my eligibility
What is being tested?
The trial is testing if Tocotrienol (TCT), taken as two capsules twice daily for three years, can slow down the worsening of the MELD score in patients with advanced liver disease compared to a placebo. The study is double-blind and randomized.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience unexpected health issues related to taking Tocotrienol over an extended period. Regular monitoring will help identify any potential side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have end-stage liver disease due to fatty liver.
Select...
My liver issues are not caused by anything else.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of Oral tocotrienols (TCT) on Model for End-Stage Liver Disease (MELD) score.
Secondary outcome measures
Adverse events
Change in ALT Alanine transaminase
Change in Child-Pugh Score
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Tocotrienol supplementActive Control1 Intervention
Subjects will take (2) 200 mg TCT capsules following AM meal, (2) 200 mg TCT following PM meal
Group II: Placebo VehiclePlacebo Group1 Intervention
Subjects will take 2 placebo capsules following AM meal, 2 placebo capsules following PM capsules
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,206 Total Patients Enrolled
Malaysia Palm Oil BoardOTHER_GOV
38 Previous Clinical Trials
3,070 Total Patients Enrolled
Raj Vuppalanchi, M.D.5.09 ReviewsPrincipal Investigator - Indiana Unviersity School of Medicine
Medical School - Gandhi Medical College and Hospital, Secunderabad, Bachelor of Medicine, Bachelor of Surgery
Long Island College Hospital, Residency in Internal Medicine
1 Previous Clinical Trials
40 Total Patients Enrolled
5Patient Review
Dr. Smith was very comprehensive in his explanation and provided a lot of useful information.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function has worsened quickly, with a significant increase in my MELD score recently.I have liver cancer.I have HIV/AIDS or another long-term immune system problem.I have hepatitis B or C.I have a bacterial infection currently.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were treated.I can attend all required study visits and follow the study rules.I have been taking more than 100 IU of vitamin E daily for the last 3 months.I do not have other major health issues reducing my life expectancy to under 3 years.I have end-stage liver disease due to fatty liver.I have or had liver cancer.I have had a liver transplant.I am 18 years old or older.I have not had weight loss surgery in the last 2 years and do not plan any during the study.I am not pregnant, breastfeeding, nor plan to become pregnant in the next 3 years.My liver issues are not caused by anything else.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Vehicle
- Group 2: Tocotrienol supplement
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks of taking Tocotrienol supplements?
"While there is some evidence that suggests Tocotrienol supplementation is safe, it only received a score of 2 because there are no clinical trials evaluating its efficacy."
Answered by AI
How many people fit the screening criteria for this research project?
"That is correct. The listing on clinicaltrials.gov currently says that the trial is open and recruiting patients. The initial posting was on November 1st, 2019 with the latest edit being on January 19th, 2022. Only one site is participating but they are looking for 70 patients in total."
Answered by AI
Are there any open slots for new patients in this trial?
"active recruitment is happening for this clinical trial, based on the information available from clinicaltrials.gov. The first posting was on 11/1/2019, and the most recent update occurred on 1/19/2022. They are looking to enroll a total of 70 patients at 1 site."
Answered by AI
Are there previous reports of Tocotrienol's efficacy?
"At the moment, there are 2 clinical trials studying Tocotrienol supplement. Of those active studies, 0 are in Phase 3. Many of the trials for Tocotrienol supplement take place in Indianapolis, Indiana; however, there are 2 locations running these sorts of tests."
Answered by AI
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