Who is sponsoring VitD_DHA?

VitD_DHA is sponsored by Bambino Gesù Hospital and Research Institute.

What condition does VitD_DHA study?

VitD_DHA studies NAFLD, Non Alcoholic Steatohepatitis (NASH).

What drugs are being tested in VitD_DHA?

Interventions: DHA plus Vitamin D, Placebo.

What is the status of VitD_DHA?

VitD_DHA is currently COMPLETED.

Last reviewed 2016-01-13 · How we verify

Efficacy and Tolerability of Vitamin D and Docosahexaenoic Acid (DHA) in Children With Biopsy Proven NAFLD (VitD_DHA)

NCT02098317 Phase 3 COMPLETED

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).

Details

Lead sponsor	Bambino Gesù Hospital and Research Institute
Phase	Phase 3
Status	COMPLETED
Enrolment	66
Start date	2014-01
Completion	2015-09

Conditions

NAFLD
Non Alcoholic Steatohepatitis (NASH)

Interventions

DHA plus Vitamin D
Placebo

Primary outcomes

Improvement in NAFLD Activity Score (NAS) — 12 months

Countries

Italy