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

Sponsor

Bambino Gesù Hospital and Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02098317

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
NAFLD Non Alcoholic Steatohepatitis (NASH)	Drug: DHA plus Vitamin D Drug: Placebo	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TREATED GROUP 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	Drug: DHA plus Vitamin D DHA 500 mg plus Vitamin D 800 IU
Placebo Comparator: PLACEBO GROUP 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	Drug: Placebo Placebo pearls mimicking pearls with DHA and Vitamin D

Arm

Intervention/Treatment

Experimental: TREATED GROUP

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

Drug: DHA plus Vitamin D

DHA 500 mg plus Vitamin D 800 IU

Placebo Comparator: PLACEBO GROUP

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

Drug: Placebo

Placebo pearls mimicking pearls with DHA and Vitamin D

Outcome Measures

Primary Outcome Measures

Improvement in NAFLD Activity Score (NAS) [12 months]

Secondary Outcome Measures

improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile [at 6 and 12 months]
safety [6 months]
clinical examination, medical history and specific laboratory parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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