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Dietary polyunsaturated fatty acids for decreasing lipid hepatic content in children with fatty liver

Evaluation on the efficacy of docosahexaenoic acid for the treatment of nonalcoholic fatty liver disease in children - DHA for fatty liver in children

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001975-36-IT
Enrollment
Unknown
Registered
2012-06-14
Start date
2012-05-24
Completion date
Unknown
Last updated
2013-01-07

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

Conditions

Nonalcoholic steatohepatitis MedDRA version: 14.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: DHA Product Code: NA Pharmaceutical Form: Chewable capsule, soft Current Sponsor code: A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmace

Sponsors

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Obese children and adolescents (BMI > 95th percentile), aged 6 to 18 years, with NAFLD Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: viral and autoimmune hepatitis, Wilson disease, and genetic and metabolic liver diseases

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate wether DHA suppementation decreases fatty liver content in children with NAFLD;Secondary Objective: To evaluate wether DHA suppementation improves liver function as well as the insulinresistance;Primary end point(s): Reduction of hepatic fat content;Timepoint(s) of evaluation of this end point: six months—

Secondary

MeasureTime frame
Secondary end point(s): improvement of liver and metabolic functions;Timepoint(s) of evaluation of this end point: three and six months—

Countries

Italy

Contacts

Public ContactUOC Oncoematologia

Lucia Pacifico, Dipartimento di Pediatria

lucia.pacifico@uniroma1.it06.49979305

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026