DHA and Vitamin D in Children With Biopsy-proven NAFLD

NCT02098317 | Completed Phase 3

• 1 other identifier: VD3_DHA_NAFLD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

NAFLD; Non Alcoholic Steatohepatitis (NASH)

Keywords

NAFLD; NASH; DHA; VITAMIN D; OBESITY; CHILDREN

Outcome Measures

Primary Outcomes (1)

• Improvement in NAFLD Activity Score (NAS)

  12 months

Secondary Outcomes (2)

• improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile

  at 6 and 12 months

• safety

  6 months

Study Arms (2)

TREATED GROUP

EXPERIMENTAL

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

PLACEBO GROUP

PLACEBO COMPARATOR

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

Interventions

DHA plus Vitamin D DRUG

DHA 500 mg plus Vitamin D 800 IU

TREATED GROUP

Placebo DRUG

Placebo pearls mimicking pearls with DHA and Vitamin D

PLACEBO GROUP

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Bambino Gesù Children Hospital

Rome, Italy, 00165, Italy

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Valerio Nobili, Professor

  Bambino Gesù Children Hospital

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 28, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

IT (1)