Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: 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
Control Interve
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 m 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of Vitamin E on Myosteatosis in patients with cirrhosis as measured by CT.Timepoint: To assess the effect of Vitamin E on Myosteatosis in patients with cirrhosis as measured by CT at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). Timepoint: 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 | — |
Countries
India
Contacts
Public ContactHARJOT SINGH
Post Graduate Institute Of Medical Research And Education
Outcome results
None listed