Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

January 9, 2009 updated by: Catalysis SL

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Vedado, Havana, Cuba, 10400
        • National Institute of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • lifestyle modification

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Adelaida Rodríguez de Miranda, MD, National Institute of Gastroenterology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

July 30, 2007

First Submitted That Met QC Criteria

July 30, 2007

First Posted (ESTIMATE)

July 31, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2009

Last Update Submitted That Met QC Criteria

January 9, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIUNASH-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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