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Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

Primary Purpose

Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Viusid
Hypocaloric Diet with controlled exercise
Sponsored by
Catalysis SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring Nonalcoholic steatohepatitis, Nonalcoholic Fatty Liver, Nutritional supplement, Diet, Exercise

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Viusid, a nutritional supplement, in combination with controlled diet and exercise

Controlled diet and exercise

Outcomes

Primary Outcome Measures

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

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)

Full Information

First Posted
July 30, 2007
Last Updated
January 9, 2009
Sponsor
Catalysis SL
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1. Study Identification

Unique Protocol Identification Number
NCT00509418
Brief Title
Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis
Official Title
Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catalysis SL

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis
Keywords
Nonalcoholic steatohepatitis, Nonalcoholic Fatty Liver, Nutritional supplement, Diet, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Viusid, a nutritional supplement, in combination with controlled diet and exercise
Arm Title
B
Arm Type
Active Comparator
Arm Description
Controlled diet and exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Viusid
Other Intervention Name(s)
Nutritional supplement
Intervention Description
Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks
Intervention Type
Other
Intervention Name(s)
Hypocaloric Diet with controlled exercise
Other Intervention Name(s)
lifestyle modification
Intervention Description
Modified ADA diet in combination with controlled exercise daily 24 weeks
Primary Outcome Measure Information:
Title
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida Rodríguez de Miranda, MD
Organizational Affiliation
National Institute of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Gastroenterology
City
Vedado
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba

12. IPD Sharing Statement

Citations:
PubMed Identifier
17311621
Citation
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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Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

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