Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

Overview

The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.

Full Title of Study: “Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study”

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 2007

Interventions

  • Dietary Supplement: Viusid
    • Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks
  • Other: Hypocaloric Diet with controlled exercise
    • Modified ADA diet in combination with controlled exercise daily 24 weeks

Arms, Groups and Cohorts

  • Experimental: A
    • Viusid, a nutritional supplement, in combination with controlled diet and exercise
  • Active Comparator: B
    • Controlled diet and exercise

Clinical Trial Outcome Measures

Primary Measures

  • The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).
    • Time Frame: 24 weeks

Secondary Measures

  • Alanine aminotransferase levels (end of the treatment), δ-glutamyltransferase levels (end of the treatment), Body weight, Body Mass Index, Waist circumference (end of the treatment) Insulin resistance (HOMA) (end of the treatment)
    • Time Frame: 24 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis) – Age between 18 and 70 years – Ability to provide informed consent – Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g) Exclusion Criteria:

  • Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency) – Pregnancy or lactation – Decompensated cirrhosis – Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery – Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil – Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter) – Contraindication to liver biopsy – Refusal to participate in the study – Concomitant disease with reduced life expectancy – Severe psychiatric conditions – Drug dependence

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Catalysis SL
  • Provider of Information About this Clinical Study
    • Eduardo Vilar Gómez, National Institute of Gastroenterology
  • Overall Official(s)
    • Adelaida Rodríguez de Miranda, MD, Principal Investigator, National Institute of Gastroenterology

References

Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x.

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