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

This study is not yet open for participant recruitment.
Verified November 2011 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01279434
First received: December 25, 2010
Last updated: November 10, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Non Alcoholic Steatohepatitis
 Drug: Vitamin E plus Pentoxiphyllin
Drug: Vitamin E

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Vitamin E
U.S. FDA Resources

Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score]) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 152
Study Start Date: January 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279434

Contacts
Contact: Dr Ramesh Kumar, MD, DM +91-11-64703890 docrameshkr@gmail.com
Contact: Dr Tarandeep Singh, MBBS, PhD +91-11-64703890 drtarandeep@gmail.com

Locations
India
Institute of Liver & Biliary Sciences Not yet recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Ramesh Kumar, MD, DM     +91-11-64703890     docrameshkr@gmail.com    
Contact: Dr Tarandeep Singh, MBBS, PhD     +91-11-64703890     drtarandeep@gmail.com    
Sub-Investigator: Dr Ramesh Kumar, MD, DM            
Sub-Investigator: Dr Tarandeep Singh, MBBS, PhD            
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Dr S.K. Sarin, MD, DM Institute of Liver and Biliary Sciences
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01279434     History of Changes
Other Study ID Numbers: ILBS/DHPT/CT/006
Study First Received: December 25, 2010
Last Updated: November 10, 2011
Health Authority: India: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013