Vitamin E in patients with Non-alcoholic steatohepatitis (NASH) related compensated cirrhosis: An open label, randomized control trial

Not yet recruiting

• Conditions: Other and unspecified cirrhosis ofliver,

• Registration Number: CTRI/2022/09/045688
• Lead Sponsor: Postgraduate Institute of Medical Education and Research

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-09
• Study Start: 2022-09-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Patients with NASH-related compensated cirrhosis belonging to CTP class A.

Exclusion Criteria

• 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.
• 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%.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development new onset hepatic decompensations in patients with NASH-related compensated cirrhosis	Follow up every 3months for 2 years post enrollment

Secondary Outcome Measures

Name	Time	Method
Development of HCC	2-years
Transplant-free survival	2 years

Trial Locations

Locations (1)

Dept of Hepatology Room no.36 Nehru Hospital Extension , PGIMER, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Dept of Hepatology Room no.36 Nehru Hospital Extension , PGIMER, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Ajay Duseja

Principal investigator

9417007416

ajayduseja@yahoo.co.in