Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

NCT ID: NCT00509418

Last Updated: 2009-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-09-30

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.

Conditions

Nonalcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

Viusid

Intervention Type: DIETARY_SUPPLEMENT

Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks

B

Controlled diet and exercise

Group Type: ACTIVE_COMPARATOR

Hypocaloric Diet with controlled exercise

Intervention Type: OTHER

Modified ADA diet in combination with controlled exercise daily 24 weeks

Interventions

Viusid

Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks

Intervention Type: DIETARY_SUPPLEMENT

Hypocaloric Diet with controlled exercise

Modified ADA diet in combination with controlled exercise daily 24 weeks

Intervention Type: OTHER

Other Intervention Names

Nutritional supplement; lifestyle modification

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catalysis SL

INDUSTRY

Sponsor Role: lead

Responsible Party

National Institute of Gastroenterology

Principal Investigators

Adelaida Rodríguez de Miranda, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Gastroenterology

Locations

National Institute of Gastroenterology

Vedado, La Habana, Cuba

Countries

Cuba

References

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.

Reference Type: BACKGROUND

PMID: 17311621 (View on PubMed)

Other Identifiers

VIUNASH-07

Identifier Type: -

Identifier Source: org_study_id