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

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.

Study Overview

• Status: Withdrawn
• Conditions: Non Alcoholic Steatohepatitis
• Intervention / Treatment: Drug: Vitamin E plus Pentoxiphyllin; Drug: Vitamin E

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitamin E plus Pentoxiphyllin	Drug: Vitamin E plus Pentoxiphyllin; Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months; Other Names: Arm A
ACTIVE_COMPARATOR: Vitamin E	Drug: Vitamin E; Vitamin E 400 mg BD daily for 12 months; Other Names: Arm B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])	Baseline and 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Ramesh Kumar, MD,DM, Institute of liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): March 1, 2012
• Study Completion (ANTICIPATED): June 1, 2012

Study Registration Dates

• First Submitted: December 25, 2010
• First Submitted That Met QC Criteria: January 15, 2011
• First Posted (ESTIMATE): January 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Tocotrienols
• Other Study ID Numbers: ILBS/DHPT/CT/006