Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial

Not Applicable

Withdrawn

• Conditions: Non Alcoholic Steatohepatitis
• Interventions: Drug: Vitamin E plus Pentoxiphyllin; Drug: Vitamin E

• Registration Number: NCT01279434
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. Since, both vitamin E and PTX has been found to improve NASH when used alone, a combination of these two should be expected to give better results because of targeting two different pathogenetic mechanisms (cytokines amplification and oxidative stress) in NASH patients. This will be open labelled, prospective, randomized study. The diagnosis of NAFLD will be made on the basis of Ultrasonographic findings suggestive of fatty liver and presence of insulin resistance or features of metabolic syndrome. Subsequently histologic confirmation of the diagnosis of NASH will be made in all cases.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-25
• Study First Submitted QC: 2011-01-15
• Study First Posted: 2011-01-19
• Status Verified: 2011-11
• Study Start: 2012-01
• Primary Completion: 2012-03
• Study Completion: 2012-06
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of NAFLD by ultrasonographic
• Presence of Insulin resistance
• Histological confirmation of NASH
• Increased transaminases (>1.5 upper limit normal [ULN])

Exclusion Criteria

• Patients with alcohol > 20g/ day
• Other known liver disease
• Medications known to induce fatty liver

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin E plus Pentoxiphyllin	Vitamin E plus Pentoxiphyllin	-
Vitamin E	Vitamin E	-

Primary Outcome Measures

Name	Time	Method
Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])	Baseline and 1 year

Secondary Outcome Measures

Name	Time	Method
Normalization of serum transaminases levels	Baseline and 1 year
Reduction in serum levels of proinflammatory cytokines (TNF-α and IL-6) and Malondialdehyde (MDA).	Baseline and 1 year
Improvement in HOMA-IR	Baseline and 1 year
No worsening of fibrosis	Baseline and 1 year

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India