Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509418
• Other study ID #: VIUNASH-07
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2007
• Last updated: January 9, 2009
• Start date: February 2007
• Est. completion date: September 2007

Study information

• Verified date: January 2009
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: National Coordinating Center of Clinical Trials (CENCEC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 a-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Nonalcoholic Steatohepatitis

Intervention

Dietary Supplement:
• Viusid
Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks

Other:
• Hypocaloric Diet with controlled exercise
Modified ADA diet in combination with controlled exercise daily 24 weeks

Locations

Country	Name	City	State
Cuba	National Institute of Gastroenterology	Vedado	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).		24 weeks	No
Secondary	Alanine aminotransferase levels (end of the treatment), d-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	No