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Trial record 17 of 609 for:    hepatic steatosis | Non-Alcoholic Steatohepatitis

Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00509418
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : January 12, 2009
Sponsor:
Information provided by:
Catalysis SL

Tracking Information
First Submitted Date  ICMJE July 30, 2007
First Posted Date  ICMJE July 31, 2007
Last Update Posted Date January 12, 2009
Study Start Date  ICMJE February 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment). [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00509418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis
Official Title  ICMJE Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Dietary Supplement: Viusid
    Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks
    Other Name: Nutritional supplement
  • Other: Hypocaloric Diet with controlled exercise
    Modified ADA diet in combination with controlled exercise daily 24 weeks
    Other Name: lifestyle modification
Study Arms
  • Experimental: A
    Viusid, a nutritional supplement, in combination with controlled diet and exercise
    Intervention: Dietary Supplement: Viusid
  • Active Comparator: B
    Controlled diet and exercise
    Intervention: Other: Hypocaloric Diet with controlled exercise
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2007)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cuba
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00509418
Other Study ID Numbers  ICMJE VIUNASH-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eduardo Vilar Gómez, National Institute of Gastroenterology
Study Sponsor  ICMJE Catalysis SL
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adelaida Rodríguez de Miranda, MD National Institute of Gastroenterology
PRS Account Catalysis SL
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP