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
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2013
CompletedFirst Posted
Study publicly available on registry
September 4, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJanuary 14, 2016
January 1, 2016
1 year
August 30, 2013
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in NAFLD Activity Score (NAS)
12 months
Secondary Outcomes (1)
Improvement of serum alanine transferase levels, lipid profile, glico-insulinemic profile (all parameters of metabolic syndrome) and bright liver at ultrasonography
6 and 12 months
Other Outcomes (1)
Safety
6 and 12 months
Study Arms (2)
TREATED GROUP
EXPERIMENTALDHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg by mouth every day in association with lifestyle intervention \[hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity\] for 6 months
PLACEBO GROUP
PLACEBO COMPARATORplacebo: this group will treated with identical placebo pearls given orally in association with lifestyle intervention \[hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity\] for 6 months
Interventions
DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg
Eligibility Criteria
You may qualify if:
- persistently elevated serum aminotransferase levels
- diffusely echogenic liver on imaging studies suggestive of fatty liver
- biopsy consistent with the diagnosis of NAFLD
You may not qualify if:
- hepatic virus infections (HCV RNA-PCR negative)
- Hepatitis A, B, C, D, E and G
- cytomegalovirus and Epstein-Barr virus
- alcohol consumption
- history of parenteral nutrition
- use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
- autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bambino Gesù Hospital and Research Institute
Rome, Rome, Italy, 00165, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerio Nobili, MD
Bambino Gesù Children Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Hepato-Metabolic Disease Unit, Bambino Gesù Children Hospital, IRCCS
Study Record Dates
First Submitted
August 30, 2013
First Posted
September 4, 2013
Study Start
October 1, 2013
Primary Completion
October 1, 2014
Study Completion
July 1, 2015
Last Updated
January 14, 2016
Record last verified: 2016-01