Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
NCT ID: NCT00063635
Last Updated: 2012-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
173 participants
INTERVENTIONAL
2005-09-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Metformin, 500 mg, twice daily
Metformin
500 mg, twice daily
2
Vitamin E, 400 IU, twice daily
Vitamin E
400 IU, twice daily
3
Matching placebo
Matching placebo
Twice daily
Interventions
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Metformin
500 mg, twice daily
Vitamin E
400 IU, twice daily
Matching placebo
Twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
8 Years
17 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Locations
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University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Indiana University
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
St. Louis University
St Louis, Missouri, United States
Case Western Reserve University
Cleveland, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Corey KE, Vuppalanchi R, Vos M, Kohli R, Molleston JP, Wilson L, Unalp-Arida A, Cummings OW, Lavine JE, Chalasani N; Nonalcoholic Steatohepatitis Clinical Research Network. Improvement in liver histology is associated with reduction in dyslipidemia in children with nonalcoholic fatty liver disease. J Pediatr Gastroenterol Nutr. 2015 Mar;60(3):360-7. doi: 10.1097/MPG.0000000000000584.
Guerrerio AL, Colvin RM, Schwartz AK, Molleston JP, Murray KF, Diehl A, Mohan P, Schwimmer JB, Lavine JE, Torbenson MS, Scheimann AO. Choline intake in a large cohort of patients with nonalcoholic fatty liver disease. Am J Clin Nutr. 2012 Apr;95(4):892-900. doi: 10.3945/ajcn.111.020156. Epub 2012 Feb 15.
Lavine JE, Schwimmer JB, Van Natta ML, Molleston JP, Murray KF, Rosenthal P, Abrams SH, Scheimann AO, Sanyal AJ, Chalasani N, Tonascia J, Unalp A, Clark JM, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; Nonalcoholic Steatohepatitis Clinical Research Network. Effect of vitamin E or metformin for treatment of nonalcoholic fatty liver disease in children and adolescents: the TONIC randomized controlled trial. JAMA. 2011 Apr 27;305(16):1659-68. doi: 10.1001/jama.2011.520.
Lavine JE, Schwimmer JB, Molleston JP, Scheimann AO, Murray KF, Abrams SH, Rosenthal P, Sanyal AJ, Robuck PR, Brunt EM, Unalp A, Tonascia J; Nonalcoholic Steatohepatitis Clinical Research Network Research Group. Treatment of nonalcoholic fatty liver disease in children: TONIC trial design. Contemp Clin Trials. 2010 Jan;31(1):62-70. doi: 10.1016/j.cct.2009.09.001. Epub 2009 Sep 15.
Related Links
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National Institute of Diabetes and Digestive and Kidney Diseases
Other Identifiers
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NASH - PEDIATRICS (IND)
Identifier Type: -
Identifier Source: org_study_id