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Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)

NCT00063635 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2012-09-27

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Metformin

500 mg, twice daily

DIETARY_SUPPLEMENT

Vitamin E

400 IU, twice daily

DRUG

Matching placebo

Twice daily

Sponsors & Collaborators

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

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-09-30
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00063635 on ClinicalTrials.gov