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DHA and Vitamin D in Children With Biopsy-proven NAFLD (VitD_DHA)

Primary Purpose

NAFLD, Non Alcoholic Steatohepatitis (NASH)

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
DHA plus Vitamin D
Placebo
Sponsored by
Bambino Gesù Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD focused on measuring NAFLD, NASH, DHA, VITAMIN D, OBESITY, CHILDREN

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • biopsy consistent with the diagnosis of NAFLD/NASH
  • reduced serum levels of vitamin D aminotransferases (ALT) levels <10 upper limit of normal
  • hyperechogenicity at liver ultrasound examination suggestive of fatty liver
  • International normalized ratio (INR) < 1,3
  • Albumin > 3 g/dl
  • total bilirubin < 2,5 mg/dl
  • no previous gastrointestinal bleeding
  • no previous portosystemic encephalopathy
  • normal renal function
  • no hepatitis B, hepatitis C infection
  • normal cell blood count

Exclusion Criteria:

  • alcohol consumption
  • 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
  • every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation
  • finding of active liver disease due to other causes

Sites / Locations

  • Bambino Gesù Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TREATED GROUP

PLACEBO GROUP

Arm Description

this group will treated with pearls containing DHA plus Vitamin D3 (500 mg and 800 IU, respectively) 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 24 weeks

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 24 weeks

Outcomes

Primary Outcome Measures

Improvement in NAFLD Activity Score (NAS)

Secondary Outcome Measures

improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile
safety
clinical examination, medical history and specific laboratory parameters

Full Information

First Posted
March 24, 2014
Last Updated
January 13, 2016
Sponsor
Bambino Gesù Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02098317
Brief Title
DHA and Vitamin D in Children With Biopsy-proven NAFLD
Acronym
VitD_DHA
Official Title
Efficacy and Tolerability of Vitamin D and Docosahexaenoic Acid (DHA) in Children With Biopsy Proven NAFLD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bambino Gesù Hospital and Research Institute

4. Oversight

5. Study Description

Brief 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).
Detailed Description
Sixty-six children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA and Vitamin D (n=33) or an identical placebo (n=33) given orally for a period of 6 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise. Patients will undergo a medical evaluation at 3-6 and 12 months during the 12-months study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric measurements and laboratory tests, including liver enzymes, gluco-insulinemic profile and lipids will be performed at baseline and repeated at 6-12 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Non Alcoholic Steatohepatitis (NASH)
Keywords
NAFLD, NASH, DHA, VITAMIN D, OBESITY, CHILDREN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TREATED GROUP
Arm Type
Experimental
Arm Description
this group will treated with pearls containing DHA plus Vitamin D3 (500 mg and 800 IU, respectively) 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 24 weeks
Arm Title
PLACEBO GROUP
Arm Type
Placebo Comparator
Arm Description
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 24 weeks
Intervention Type
Drug
Intervention Name(s)
DHA plus Vitamin D
Intervention Description
DHA 500 mg plus Vitamin D 800 IU
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pearls mimicking pearls with DHA and Vitamin D
Primary Outcome Measure Information:
Title
Improvement in NAFLD Activity Score (NAS)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile
Time Frame
at 6 and 12 months
Title
safety
Description
clinical examination, medical history and specific laboratory parameters
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: biopsy consistent with the diagnosis of NAFLD/NASH reduced serum levels of vitamin D aminotransferases (ALT) levels <10 upper limit of normal hyperechogenicity at liver ultrasound examination suggestive of fatty liver International normalized ratio (INR) < 1,3 Albumin > 3 g/dl total bilirubin < 2,5 mg/dl no previous gastrointestinal bleeding no previous portosystemic encephalopathy normal renal function no hepatitis B, hepatitis C infection normal cell blood count Exclusion Criteria: alcohol consumption 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 every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation finding of active liver disease due to other causes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerio Nobili, Professor
Organizational Affiliation
Bambino Gesù Children Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bambino Gesù Children Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy

12. IPD Sharing Statement

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DHA and Vitamin D in Children With Biopsy-proven NAFLD

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