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Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00509418
First received: July 30, 2007
Last updated: January 9, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Nonalcoholic Steatohepatitis
 Dietary Supplement: Viusid
Other: Hypocaloric Diet with controlled exercise
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Viusid, a nutritional supplement, in combination with controlled diet and exercise
 Dietary Supplement: Viusid
Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks
Other Name: Nutritional supplement
Active Comparator: B
Controlled diet and exercise
 Other: Hypocaloric Diet with controlled exercise
Modified ADA diet in combination with controlled exercise daily 24 weeks
Other Name: lifestyle modification

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509418

Locations
Cuba
National Institute of Gastroenterology
Vedado, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Adelaida Rodríguez de Miranda, MD National Institute of Gastroenterology
  More Information

Publications:

Responsible Party: Eduardo Vilar Gómez, National Institute of Gastroenterology
ClinicalTrials.gov Identifier: NCT00509418     History of Changes
Other Study ID Numbers: VIUNASH-07
Study First Received: July 30, 2007
Last Updated: January 9, 2009
Health Authority: Cuba: National Coordinating Center of Clinical Trials (CENCEC)

Keywords provided by Catalysis SL:
Nonalcoholic steatohepatitis
Nonalcoholic Fatty Liver
Nutritional supplement
Diet
Exercise

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013