Completed PHASE3 INTERVENTIONAL 2-arm NCT01934777

Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

Study of Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

Sponsor: Bambino Gesù Hospital and Research Institute

Conditions Fatty Liver Liver Fibrosis Metabolic Syndrome Nonalcoholic Fatty Liver Disease Obesity

Interventions Docosahexaenoic Acid plus Vitamin E plus choline placebo pearls

Updated 5 times since 2017 Last updated: Jan 13, 2016 Started: Oct 31, 2013 Primary completion: Oct 31, 2014 Completion: Jul 31, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01934777, this PHASE3 trial focuses on Fatty Liver and Liver Fibrosis and remains completed. Sponsored by Bambino Gesù Hospital and Research Institute, it has been updated 5 times since 2013, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Oct 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bambino Gesù Hospital and Research Institute

Data source: Bambino Gesù Hospital and Research Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Rome, Italy