Tocotrienol Against the Progression of End Stage Liver Disease
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|ClinicalTrials.gov Identifier: NCT02581085|
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : November 14, 2019
|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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
Placebo Comparator: Placebo Vehicle
Subjects will take 2 placebo capsules following AM meal, 2 placebo capsules following PM capsules
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.
- 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
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
|Contact: Jennifer Mohnacky, RNfirstname.lastname@example.org|
|Contact: Sashwati Roy, Ph.Demail@example.com|
|Study Chair:||Chandan K Sen, Ph.D||Indiana University School of Medicine|
|Principal Investigator:||Raj Vuppalanchi, M.D.||Indiana Unviersity School of Medicine|