MedTrace Logo

Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)

NCT00885313 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-05-13

No results posted yet for this study

Summary

The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

Conditions

Interventions

DRUG

DHA250

DHA 250 mg/kg/d

DRUG

DHA500

DHA 500 mg/kg/d

DRUG

PLACEBO

placebo

BEHAVIORAL

Lifestyle intervention

lifestyle intervention \[including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity\], for 12 months.

Sponsors & Collaborators

  • Bambino Gesù Hospital and Research Institute

    lead OTHER

Principal Investigators

  • Valerio Nobili, MD · Bambino Gesù Children Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-04-30
Completion
2011-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
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 NCT00885313 on ClinicalTrials.gov