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DHA and Vitamin D in Children With Biopsy-proven NAFLD

NCT02098317 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2016-01-14

No results posted yet for this study

Summary

Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression.

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

Conditions

  • NAFLD
  • Non Alcoholic Steatohepatitis (NASH)

Interventions

DRUG

DHA plus Vitamin D

DHA 500 mg plus Vitamin D 800 IU

DRUG

Placebo

Placebo pearls mimicking pearls with DHA and Vitamin D

Sponsors & Collaborators

  • Bambino Gesù Hospital and Research Institute

    lead OTHER

Principal Investigators

  • Valerio Nobili, Professor · Bambino Gesù Children Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-05-31
Completion
2015-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT02098317 on ClinicalTrials.gov