Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

Phase 3

Completed

• Conditions: Nonalcoholic Steatohepatitis
• Interventions: Dietary Supplement: Viusid; Other: Hypocaloric Diet with controlled exercise

• Registration Number: NCT00509418
• Lead Sponsor: Catalysis SL

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 available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-07-30
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-09
• Last Update Posted: 2009-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Viusid	Viusid, a nutritional supplement, in combination with controlled diet and exercise
B	Hypocaloric Diet with controlled exercise	Controlled diet and exercise

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	24 weeks

Trial Locations

Locations (1)

National Institute of Gastroenterology; 🇨🇺 Vedado, Havana, Cuba