CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 90 enrolled
Drug / intervention
Vitamin treatment (alpha tocopherol plus ascorbic acid) +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00655018
NCT00655018Phase 3Completed
CompareCT.gov

Lifestyle Intervention and Antioxidants in Children With Nonalcoholic Fatty Liver Disease: A Randomized, Controlled Trial

Bambino Gesù Hospital and Research Institute·interventional·Posted Apr 9, 2008·Updated Apr 9, 2008

In Brief

A Phase 3 clinical trial evaluating Vitamin treatment (alpha tocopherol plus ascorbic acid) and Placebo for Inflammation and 2 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammation, Fibrosis, Insulin Resistance
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2008
Enrollment StartJan 1, 2003
Primary CompletionOct 1, 2006
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.2 years ago

Interventions

Vitamin treatment (alpha tocopherol plus ascorbic acid)dietary

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

Placebodietary

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