Metadoxine as a Therapy for Severe Alcoholic Hepatitis


The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.

Full Title of Study: “Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2014


  • Drug: Prednisone plus Metadoxine
  • Drug: Pentoxifylline plus Metadoxine

Arms, Groups and Cohorts

  • No Intervention: Prednisone
    • Prednisone 40 mg daily by mouth during 30 days.
  • No Intervention: Pentoxifylline
    • Pentoxifylline 400 mg thrice in day by mouth during 30 days
  • Experimental: Prednisone plus metadoxine
    • Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
  • Experimental: Pentoxifylline plus metadoxine
    • Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.

Clinical Trial Outcome Measures

Primary Measures

  • 30 day-survival
    • Time Frame: 30 days
  • Malondialdehyde serum levels
    • Time Frame: 14 and 30 days

Secondary Measures

  • 3 month-survival
    • Time Frame: 3 months
  • 6 month-survival
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32. Exclusion Criteria:

  • Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital General de Mexico
  • Provider of Information About this Clinical Study
    • Principal Investigator: MARIA DE FATIMA HIGUERA DE LA TIJERA, MD, MSc. – Hospital General de Mexico

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.