Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)

Study of Efficacy and Tolerability of Docosahexaenoic Acid (DHA) on Children Affected by Nonalcoholic Fatty Liver Disease (NAFLD).

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00885313

Acronym

EDACN

Enrollment

Registered

2009-04-21

Start date

2009-03-31

Completion date

2011-03-31

Last updated

2011-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver, Liver Fibrosis, Metabolic Syndrome, Nonalcoholic Fatty Liver Disease, Obesity

Keywords

NAFLD, NASH, fibrosis

Brief summary

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

Detailed description

Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA 250 mg/kg/d (n=20), DHA 500 mg/kg/d (n=20), or an identical placebo (n=20) given orally for a period of 24 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 24-month study period. Liver biopsy will be performed only at baseline and at the end of treatment. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 24-month study duration. Ultrasonography and Fibroscan of the liver will be repeated at the end of the study period.

Interventions

DRUGDHA250

DHA 250 mg/kg/d

DRUGDHA500

DHA 500 mg/kg/d

DRUGPLACEBO

placebo

BEHAVIORALLifestyle intervention

lifestyle intervention \[including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity\], for 12 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

4 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Liver status by liver biopsy (steatosis and fibrosis)	months 24

Secondary

Measure	Time frame
Serum alanine transferase levels	month 24
Serum levels of triglycerides	24 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026