FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089875 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 29/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the efficacy of vitamin E in combination with standard medical treatment vs standard medical treatment alone on muscle fat level in patients with liver cirrhosis 
Scientific Title of Study   Efficacy of vitamin E in combination with standard medical treatment vs standard medical treatment alone on myosteatosis in patients with cirrhosis a randomised controlled trial 
Trial Acronym  VITEL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUNIL TANEJA 
Designation  ADDITIONAL PROFESSOR 
Affiliation  Post Graduate Institute Of Medical Research And Education 
Address  Department of Hepatology, NHE, PGIMER, Sector 12,Chandigarh
Department of Hepatology, NHE, PGIMER, Sector 12,Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9592160444  
Fax    
Email  drsuniltaneja@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  HARJOT SINGH 
Designation  SENIOR RESIDENT 
Affiliation  Post Graduate Institute Of Medical Research And Education 
Address  Department of Hepatology, NHE, PGIMER, Sector 12,Chandigarh
Department of Hepatology, NHE, PGIMER, Sector 12,Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  7009947337  
Fax    
Email  oberoiharjot@ymail.com  
 
Details of Contact Person
Public Query  
Name  HARJOT SINGH 
Designation  SENIOR RESIDENT 
Affiliation  Post Graduate Institute Of Medical Research And Education 
Address  Department of Hepatology, NHE, PGIMER, Sector 12,Chandigarh
Department of Hepatology, NHE, PGIMER, Sector 12,Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  7009947337  
Fax    
Email  oberoiharjot@ymail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF HEPATOLOGY, PGIMER CHANDIGARH, SECTOR 12, CHANDIGARH, INDIA, PIN-160012  
 
Primary Sponsor  
Name  PGIMER 
Address  Department of Hepatology, NHE, PGIMER, Chandigarh 
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 
Harjot Singh  PGIMER CHANDIGARH   Room Number :31 ,Department of Hepatology, PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH 		 7009947337

oberoiharjot@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instiutional Ethics Committee, PGIMER,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  The comparator arm will receive Standard medical treatment 
Intervention  VITAMIN E  The intervention group will receive Vitamin E along with the standard medical therapy where as the comparator arm will receive only standard medical treatment  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age between 18-75 years
2. Cirrhosis of any etiology with CTP score less than and equal to 10
3. Evidence of myosteatosis on CT.
 
 
ExclusionCriteria 
Details  1. CTP score greater than 10
2. Acute on chronic liver failure (ACLF)
3. Active malignancy, hepatocellular carcinoma, or end-stage renal disease
4. Prior study enrollment or concurrent enrollment in conflicting studies
5. Non-consenting patients
6. Recent participation in other clinical trials (within 3 months)
7. Active infection
8. Acute organic brain disease within the last 6 months
9. Severe hemodynamic instability, significant heart disease, bradycardia, or tachycardia
10. Renal failure with creatinine clearance rate less than 60 mL/min/1.73 m²
11. Severe cognitive impairment, overt hepatic encephalopathy, or physical disability
12. Pregnancy or breastfeeding
13. Post-liver transplant patients
14. Previous exposure to Vitamin E within 12 weeks
15. Known hypersensitivity to Vitamin E
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Vitamin E on Myosteatosis in patients with cirrhosis as measured by CT.  To assess the effect of Vitamin E on Myosteatosis in patients with cirrhosis as measured by CT at 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the effect on sarcopenia (skeletal muscle at L3 vertebral level on CT), “Subcutaneous Adipose Tissue (SAT)”, “Visceral Adipose Tissue (VAT)” and “Total Body Fat (TBF)” at 6 months.
2. Effect of Vitamin E on Frailty.
3. To study changes in levels of ammonia and inflammatory marker- CRP, ESR and IL6 at 6 months.
4. To study the change in prognostic scores (CTP, MELD, MELD Na & MELD 3.0) at 6 months.
5. Survival & hospitalization owing to complications of cirrhosis.
6. Change in quality of life at 6 months.
7. Adverse events as per World Health Organization (WHO grading).
 		 Patients will be enrolled in an expected period of 18 months
Patients will be followed up for their final outcomes for next 6 months with measurements of various outcomes at baseline and at 6 month  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/07/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Cirrhosis is a progressive liver disease marked by fibrosis and structural liver damage, leading to significant morbidity and mortality. One of its under-recognized but clinically significant complications is myosteatosis, characterized by pathological fat infiltration within skeletal muscle. Myosteatosis is closely linked with sarcopenia, frailty, poor physical performance, and increased mortality in cirrhotic patients. Despite standard medical treatment (SMT), muscle loss and fat infiltration persist, highlighting the need for adjunctive therapies.

Vitamin E, a potent fat-soluble antioxidant, may offer therapeutic benefit in myosteatosis by mitigating oxidative stress and inflammation—key drivers in muscle deterioration in cirrhosis. Preliminary studies have indicated potential improvements in muscle function and hepatic parameters with vitamin E supplementation. However, high-quality clinical evidence in this population is lacking.

This prospective, open-label, randomized controlled trial at PGIMER, Chandigarh, aims to evaluate the efficacy of Vitamin E (400 mg BID for 6 months) in combination with SMT versus SMT alone in 100 cirrhotic patients with radiologically confirmed myosteatosis. Key outcomes include changes in muscle radiodensity (HU) at L3 vertebra, skeletal muscle index (SMI), inflammatory markers (CRP, IL-6), ammonia levels, frailty index, quality of life, and prognostic liver scores (CTP, MELD). Radiological assessments via CT, handgrip strength, and bioelectrical impedance analysis (BIA) will be utilized for objective measurements.

The hypothesis is that vitamin E supplementation will lead to improved muscle composition, reduced systemic inflammation, better clinical outcomes, and improved survival. The study also seeks to address the lack of standardized treatment strategies for myosteatosis in cirrhosis and may potentially redefine management protocols.

By generating evidence on vitamin E’s efficacy, this trial could contribute significantly to improving quality of life and reducing complications in cirrhotic patients, thereby filling a critical gap in hepatology research.

 
Close