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CTRI Number  CTRI/2022/09/045688 [Registered on: 20/09/2022] Trial Registered Prospectively
Last Modified On: 03/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Vitamin E in patients with Non-alcoholic steatohepatitis (NASH) related compensated cirrhosis: An open label, randomized control trial 
Scientific Title of Study   Impact of Vitamin E (alpha-tocopherol) therapy on long-term outcomes in patients with Non-alcoholic steatohepatitis (NASH) related compensated cirrhosis: An open label, randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajay Duseja 
Designation  Professor, Department of Hepatology, PGIMER, Chandigarh 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  Department of Hepatology, Room No 36, Ground Floor, Nehru Hospital Extension Block, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9417007416  
Fax    
Email  ajayduseja@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Arka De 
Designation  Assistant Professor, Dept of Hepatology 
Affiliation  PGIMER 
Address  Department of Hepatology, Room No 33, Ground Floor, Nehru Hospital Extension Block, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9999816539  
Fax    
Email  arkascore@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arka De 
Designation  Assistant Professor, Dept of Hepatology 
Affiliation  PGIMER 
Address  Department of Hepatology, Room No 33, Ground Floor, Nehru Hospital Extension Block, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9999816539  
Fax    
Email  arkascore@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research, Chandigarh, India 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research 
Address  Sector 12, Chandigarh 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ajay Duseja  Dept of Hepatology Room no.36 Nehru Hospital Extension , PGIMER, Chandigarh  Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH 		 9417007416

ajayduseja@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Postgraduate institute of Medical education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard medical therapy  Standard medical therapy will include lifestyle interventions in the form of exercise, dietary calorie restriction and control of metabolic risk factors 
Intervention  Vitamin E   Vitamin E (400 mg) twice a day for 2-years along with standard medical therapy (SMT) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with NASH-related compensated cirrhosis belonging to CTP class A 
 
ExclusionCriteria 
Details  1. Patients who decline to give consent.
2. Patients who are non-cirrhotic or have advanced fibrosis only.
3. Patients with current or past history of decompensation(s) (clinical jaundice, ascites, hepatic encephalopathy, and portal hypertension related bleeding).
4. Patients belonging to CTP class B or C.
5. Patients presenting with acute-on-chronic liver failure (ACLF)[30].
6. Patients with present or past clinical or imaging evidence of hepatocellular carcinoma/other malignancy(s).
7. Patients with present or past available data suggestive of any other competing or confounding etiologies for underlying cirrhosis.
8. Patients with severe cardio-pulmonary disease defined as NYHA class more than II, EF <40-45%, FEV1/FVC<60%.
9. Patient with severe renal insufficiency (eGFR < 30 ml/min/1.73 m2) or those requiring maintenance hemodialysis.
10. Patients on metformin, pioglitazone, liraglutide, saroglitazar or any other experimental/off-label treatment for NAFLD/NASH.
11. Patients who are pregnant or planning conception or are lactating.
12. Patients in whom FibroScan® evaluation fails.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Development new onset hepatic decompensations in patients with NASH-related compensated cirrhosis

 		 Follow up every 3months for 2 years post enrollment  
 
Secondary Outcome  
Outcome  TimePoints 
Development of HCC  2-years 
Transplant-free survival  2 years 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ajayduseja@yahoo.co.in].

  6. For how long will this data be available start date provided 10-11-2025 and end date provided 10-11-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Vitamin E (alpha-tocopherol) is a well-known antioxidant that can protect the structural integrity of cells against injury. Several randomized controlled trials (RCTs) have explored the efficacy of supplementation with vitamin E 800 international units (IU)/day on liver histology and aminotransferase levels of patients with NASH. In two well-designed RCTs conducted in adult (PIVENS TRIAL) and pediatric (TONIC TRIAL) biopsy-proven NASH, vitamin E was associated with significant improvement in NASH histology, although there was no significant regression in liver fibrosis compared with the placebo group. However, a recent retrospective study showed that Vitamin E (800 IU/ day) decreased the risk of death or liver-transplant and hepatic decompensation in patients with biopsy-proven NASH and bridging fibrosis or cirrhosis.

In this study, we aim to prospectively assess the impact of long-term vitamin-E (alpha-tocopherol) administration in a cohort of patients with NASH-related compensated cirrhosis with respect to development of hepatic decompensation, HCC and transplant free survival at 2 years post initiation of vitamin-E treatment.

 
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