DHA and Vitamin D in Children With Biopsy-proven NAFLD

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bambino Gesù Hospital and Research Institute
• Treatments: Ergocalciferols; Vitamin D; Vitamins

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