Dietary polyunsaturated fatty acids for decreasing lipid hepatic content in children with fatty liver
- Conditions
- onalcoholic steatohepatitisMedDRA version: 14.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-001975-36-IT
- Lead Sponsor
- AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
viral and autoimmune hepatitis, Wilson disease, and genetic and metabolic liver diseases
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): improvement of liver and metabolic functions;Timepoint(s) of evaluation of this end point: three and six months