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

Sponsor
Institute of Liver and Biliary Sciences, India (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01279434
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
5
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Vitamin E plus Pentoxiphyllin
  • Drug: Vitamin E
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2012
Anticipated Primary Completion Date :
Mar 1, 2012
Anticipated Study Completion Date :
Jun 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Normalization of serum transaminases levels [Baseline and 1 year]

    2. Reduction in serum levels of proinflammatory cytokines (TNF-α and IL-6) and Malondialdehyde (MDA). [Baseline and 1 year]

    3. Improvement in HOMA-IR [Baseline and 1 year]

    4. No worsening of fibrosis [Baseline and 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institute of Liver and Biliary Sciences, India
    ClinicalTrials.gov Identifier:
    NCT01279434
    Other Study ID Numbers:
    • ILBS/DHPT/CT/006
    First Posted:
    Jan 19, 2011
    Last Update Posted:
    May 28, 2015
    Last Verified:
    Nov 1, 2011
    Additional relevant MeSH terms:
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Vitamins
    Vitamin E
    Tocopherols
    Tocotrienols
    alpha-Tocopherol

    Study Results

    No Results Posted as of May 28, 2015