DHA and Vitamin D in Children With Biopsy-proven NAFLD

NAFLD Clinical Trial

— VitD_DHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098317
• Other study ID #: VD3_DHA_NAFLD
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2014
• Last updated: January 13, 2016
• Start date: January 2014
• Est. completion date: September 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

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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

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
• NAFLD
• Non Alcoholic Steatohepatitis (NASH)

Intervention

Drug:
• DHA plus Vitamin D
DHA 500 mg plus Vitamin D 800 IU
• Placebo
Placebo pearls mimicking pearls with DHA and Vitamin D

Locations

Country	Name	City	State
Italy	Bambino Gesù Children Hospital	Rome

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
Primary	Improvement in NAFLD Activity Score (NAS)		12 months	No
Secondary	improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile		at 6 and 12 months	No
Secondary	safety	clinical examination, medical history and specific laboratory parameters	6 months	Yes