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

NCT01279434 | Withdrawn

• 1 other identifier: ILBS/DHPT/CT/006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])

  Baseline and 1 year

Secondary Outcomes (4)

• 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

Study Arms (2)

Vitamin E plus Pentoxiphyllin

EXPERIMENTAL

Drug: Vitamin E plus Pentoxiphyllin

Vitamin E

ACTIVE COMPARATOR

Drug: Vitamin E

Interventions

Vitamin E plus Pentoxiphyllin DRUG

Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months

Also known as: Arm A

Vitamin E plus Pentoxiphyllin

Vitamin E DRUG

Vitamin E 400 mg BD daily for 12 months

Also known as: Arm B

Vitamin E

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of NAFLD by ultrasonographic
• Presence of Insulin resistance
• Histological confirmation of NASH
• Increased transaminases (\>1.5 upper limit normal \[ULN\])

You may not qualify if:

• Patients with alcohol \> 20g/ day
• Other known liver disease
• Medications known to induce fatty liver

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dr Ramesh Kumar, MD,DM

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2010
• First Posted: January 19, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 28, 2015

Record last verified: 2011-11

Locations

IN (1)