DHA and Vitamin D in Children With Biopsy-proven NAFLD

NCT ID: NCT02098317

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-09-30

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

Conditions

NAFLD; Non Alcoholic Steatohepatitis (NASH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

DHA plus Vitamin D

Intervention Type: DRUG

DHA 500 mg plus Vitamin D 800 IU

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo pearls mimicking pearls with DHA and Vitamin D

Interventions

DHA plus Vitamin D

DHA 500 mg plus Vitamin D 800 IU

Intervention Type: DRUG

Placebo

Placebo pearls mimicking pearls with DHA and Vitamin D

Intervention Type: DRUG

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Valerio Nobili

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valerio Nobili, Professor

Role: PRINCIPAL_INVESTIGATOR

Bambino Gesù Children Hospital

Locations

Bambino Gesù Children Hospital

Rome, Italy, Italy

Countries

Italy

Other Identifiers

VD3_DHA_NAFLD

Identifier Type: -

Identifier Source: org_study_id