NCT00509418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 12, 2009

Status Verified

January 1, 2009

Enrollment Period

7 months

First QC Date

July 30, 2007

Last Update Submit

January 9, 2009

Conditions

Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic steatohepatitisNonalcoholic Fatty LiverNutritional supplementDietExercise

Outcome Measures

Primary Outcomes (1)

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

    24 weeks

Secondary Outcomes (1)

  • 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

Study Arms (2)

A

EXPERIMENTAL

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

Dietary Supplement: Viusid

B

ACTIVE COMPARATOR

Controlled diet and exercise

Other: Hypocaloric Diet with controlled exercise

Interventions

ViusidDIETARY_SUPPLEMENT

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

Also known as: Nutritional supplement
A
Hypocaloric Diet with controlled exerciseOTHER

Modified ADA diet in combination with controlled exercise daily 24 weeks

Also known as: lifestyle modification
B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Gastroenterology

Vedado, La Habana, 10400, Cuba

Location

Related 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. doi: 10.1111/j.1478-3231.2006.01411.x.

    PMID: 17311621BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMotor Activity

Interventions

ViusidDietary Supplements

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesBehavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Adelaida Rodríguez de Miranda, MD

    National Institute of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 30, 2007

First Posted

July 31, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 12, 2009

Record last verified: 2009-01

Locations

CU(1)