Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC) - Full Text View

Purpose

The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.

Condition	Intervention	Phase
Fatty Liver	Drug: Metformin Dietary Supplement: Vitamin E Drug: Matching placebo	Phase III

MedlinePlus related topics:

Liver Diseases

ChemIDplus related topics:

Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Sustained reduction in ALT to either 50% of baseline value or < 40 U/L [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sustained reduction in serum AST [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Sustained reduction in serum GGT [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Change in histologic feature scores determined by standardized scoring of liver biopsies at baseline and after 96 weeks of treatment [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Change in liver fibrosis, inflammation, or steatosis [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Change in body mass index [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Change in insulin resistance indices [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Change in serum vitamin E levels [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Change in serum lipid profile [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Change in QOL scores [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	August 2005
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
1: Active Comparator Metformin, 500 mg, twice daily	Drug: Metformin 500 mg, twice daily
2: Active Comparator Vitamin E, 400 IU, twice daily	Dietary Supplement: Vitamin E 400 IU, twice daily
3: Placebo Comparator Matching placebo	Drug: Matching placebo Twice daily

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Age 8-17 years at first screening visit
Histologic evidence of Nonalcoholic Fatty Liver Disease (NAFLD) - biopsy cannot be older than 6 months as of randomization
ALT level >60 U/L at time of screening and on one previous occasion determined at least one month but no greater than 6 months prior to screening ALT
Consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063635

Locations


United States, California
	University of California, San Diego
	San Diego, California, United States, 92103
	University of California, San Francisco
	San Francisco, California, United States, 94143

United States, District of Columbia
	Children's National Medical Center
	Washington, District of Columbia, United States, 20010

United States, Indiana
	Indiana University
	Indianapolis, Indiana, United States, 46202

United States, Maryland
	Johns Hopkins University
	Baltimore, Maryland, United States, 21205

United States, Missouri
	St. Louis University
	St. Louis, Missouri, United States, 63110

United States, Ohio
	Case Western Reserve University
	Cleveland, Ohio, United States, 44109

United States, Texas
	Texas Children's Hospital
	Houston, Texas, United States, 77030

United States, Virginia
	Virginia Commonwealth University
	Richmond, Virginia, United States, 23298

United States, Washington
	University of Washington
	Seattle, Washington, United States, 98195

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

National Institute of Diabetes and Digestive and Kidney Diseases This link exits the ClinicalTrials.gov site

Responsible Party:	NIDDK ( Patricia Robuck )
Study ID Numbers:	NASH - PEDIATRICS
First Received:	July 1, 2003
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00063635
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Non alcoholic fatty liver disease

Study placed in the following topic categories:

Tocopherols

Tocopherol acetate

Vitamin E

Liver Diseases

Non-alcoholic steatohepatitis (NASH)

Metformin

Fatty Liver

Alpha-Tocopherol

Additional relevant MeSH terms:

Digestive System Diseases

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00063635