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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Interventions

  • Drug: Vitamin E plus Pentoxiphyllin
    • Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months
  • Drug: Vitamin E
    • Vitamin E 400 mg BD daily for 12 months

Arms, Groups and Cohorts

  • Experimental: Vitamin E plus Pentoxiphyllin
  • Active Comparator: Vitamin E

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Liver and Biliary Sciences, India
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr Ramesh Kumar, MD,DM, Principal Investigator, Institute of Liver and Biliary Sciences

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