Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

Obesity Clinical Trial

Official title:

Study of Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934777
• Other study ID #: OPBG-DHA, VIT E, CHOLINE
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2013
• Last updated: January 13, 2016
• Start date: October 2013
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

Description:

Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA, VIT E and Choline (n=30)or an identical placebo (n=30) given orally for a period of 12 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 every three months during the 12-month study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 12-months study duration. Ultrasonography of the liver will be repeated after six months at the end of the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

Inclusion Criteria:

• persistently elevated serum aminotransferase levels

• diffusely echogenic liver on imaging studies suggestive of fatty liver

• biopsy consistent with the diagnosis of NAFLD

Exclusion Criteria:

• hepatic virus infections (HCV RNA-PCR negative)

• Hepatitis A, B, C, D, E and G

• cytomegalovirus and Epstein-Barr virus

• alcohol consumption

• history of parenteral nutrition

• 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 were ruled out using standard clinical, laboratory and histological criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Liver Fibrosis
• Metabolic Syndrome
• Metabolic Syndrome X
• Nonalcoholic Fatty Liver Disease
• Obesity

Intervention

Drug:
• Docosahexaenoic Acid plus Vitamin E plus choline
DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg
• placebo pearls
placebo

Locations

Country	Name	City	State
Italy	Bambino Gesù Hospital and Research Institute	Rome	Rome, Italy

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	clinical examination, medical history and specific laboratory parameters	6 and 12 months	Yes
Primary	Improvement in NAFLD Activity Score (NAS)		12 months	Yes
Secondary	Improvement of serum alanine transferase levels, lipid profile, glico-insulinemic profile (all parameters of metabolic syndrome) and bright liver at ultrasonography		6 and 12 months	Yes