Phase 3 N=173 Randomized Triple-blind Treatment

Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)

Fatty Liver

Bottom Line

View on ClinicalTrials.gov: NCT00063635 ↗

Enrolled (actual)

173

Serious AEs

15.6%

Results posted

Sep 2012

Primary outcome: Primary: Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L — 9; 15; 10 participants — p=0.26

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Metformin (Drug); Vitamin E (Dietary_supplement); Matching placebo (Drug)
Age: Pediatric · 8+ yrs
Sex: All
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L	9; 15; 10	0.26
SECONDARY Change in Serum Aspartate Aminotransferase (AST)	-21.5; -22.8; -20.4	0.32
SECONDARY Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment	-1.1; -1.8; -0.7	0.02 sig
SECONDARY Number of Participants With Improvement in Liver Fibrosis Score	22; 18; 19	0.71
SECONDARY Number of Participants With Improvement in Steatosis Score	26; 27; 19	0.18
SECONDARY Number of Participants With Improvement in Lobular Inflammation Score	23; 22; 20	0.89
SECONDARY Number of Participants With Improvement in Ballooning Degradation Score	22; 22; 10	0.02 sig
SECONDARY Change in Body Mass Index	1.3; 2.1; 1.9	0.77
SECONDARY Change in Serum Vitamin E Levels	-0.5; 9.4; -0.9	<0.001 sig
SECONDARY Change in Quality of Life (QOL) Scores- Physical Health	5.4; 7.6; 5.4	0.08
SECONDARY Change in QOL- Psychosocial Health	4.0; 6.0; 5.6	0.15

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00063635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.