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

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ClinicalTrials.gov Identifier: NCT01279434
Recruitment Status : Withdrawn
First Posted : January 19, 2011
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non Alcoholic Steatohepatitis Drug: Vitamin E plus Pentoxiphyllin Drug: Vitamin E Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial
Study Start Date : January 2012
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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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 Name: Arm A
Active Comparator: Vitamin E Drug: Vitamin E
Vitamin E 400 mg BD daily for 12 months
Other Name: Arm B


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

Secondary Outcome Measures :
  1. Normalization of serum transaminases levels [ Time Frame: Baseline and 1 year ]
  2. Reduction in serum levels of proinflammatory cytokines (TNF-α and IL-6) and Malondialdehyde (MDA). [ Time Frame: Baseline and 1 year ]
  3. Improvement in HOMA-IR [ Time Frame: Baseline and 1 year ]
  4. No worsening of fibrosis [ Time Frame: Baseline and 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279434


Locations
India
Institute of Liver & Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Dr Ramesh Kumar, MD,DM Institute of Liver and Biliary Sciences
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01279434     History of Changes
Other Study ID Numbers: ILBS/DHPT/CT/006
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: November 2011

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
 alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents