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Clinical Research Network in Non-alcoholic Steatohepatitis - Pediatric Trial

This study is not yet open for patient recruitment.

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)

Purpose

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 Treatment or Intervention Phase
Fatty Liver
 Drug: Metformin
 Drug: Vitamin E
 Drug: Placebo
Phase III

MedlinePlus related topics:  Liver Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Eligibility

Ages Eligible for Study:  8 Years   -   15 Years,  Genders Eligible for Study:  Both

Criteria


Location Information


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

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

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

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

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

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

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

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

More Information

National Institute of Diabetes and Digestive and Kidney Diseases

Study ID Numbers:  NASH - PEDIATRICS
Record last reviewed:  July 2004
Record first received:  July 1, 2003
ClinicalTrials.gov Identifier:  NCT00063635
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20
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