Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Fatty Liver

Treatments: Drug: Matching placebo; Drug: Metformin; Dietary Supplement: Vitamin E

Study type: Interventional

Funder types: NIH

Identifiers

NCT00063635

NASH - PEDIATRICS (IND)

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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173 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Metformin, 500 mg, twice daily

Treatment:

Drug: Metformin

2

Active Comparator group

Description:

Vitamin E, 400 IU, twice daily

Treatment:

Dietary Supplement: Vitamin E

3

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Matching placebo