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Effect of Vitamin E on Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)

NCT00655018 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2008-04-09

No results posted yet for this study

Summary

No proven treatment exists for nonalcoholic fatty liver disease (NAFLD) in children and adolescents. We aim to determine the efficacy of lifestyle intervention with or without antioxidant therapy in pediatric NAFLD.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin treatment (alpha tocopherol plus ascorbic acid)

alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].

DIETARY_SUPPLEMENT

Placebo

placebo and lifestyle intervention \[hypocaloric Diet(25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].

Sponsors & Collaborators

  • Bambino Gesù Hospital and Research Institute

    lead OTHER

Principal Investigators

  • Valerio Nobili, MD · Bambino Gesù Hospital and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

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 NCT00655018 on ClinicalTrials.gov