Clinical trial · Interventional
Hepatoprotective Measures for Children at High Risk of NAFLD
Hepatoprotective Measures for Children at High Risk of Non Alcoholic Fatty Liver Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Non Alcoholic Fatty Liver Disease (NAFLD) is a spectrum of disease, ranging from simple fatty deposition (steatosis) to inflammation (steatohepatitis), fibrosis, cirrhosis, and end-stage liver failure. In childhood, it may be associated with a metabolic syndrome or with obesity, or even in normal children. Liver biopsy has always been the gold standard method for diagnosing and staging NAFLD. However, the urge of non-invasive biomarkers or imaging techniques has been recommended. This study will evaluate the use of the LIVERFASt biomarkers for early detection and staging of NAFLD.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Non Alcoholic Fatty Liver Diseases (NAFLD) | — | UNRESOLVED | — |
| Obesity and Overweight | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet according to NASPGHAN guidelines | Behavioral | — | UNRESOLVED |
| Mediterrenean diet | Behavioral | — | UNRESOLVED |
| Omega -3 fatty acids | Dietary Supplement | — | UNRESOLVED |
| Physical exercise | Behavioral | — | UNRESOLVED |
| Ursodeoxycholic Acid 250 Mg Oral Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm (1)
- description
- Patients will follow Mediterranean Diet (MD) for 12 weeks, this diet is characterized by a high intake of vegetables, fruit, whole cereals, legumes, nuts, and fish and a low intake of red meat and homemade desserts. The main added fat is extra virgin olive oil, with 35-40% kcal from fat (\<10% from saturated fat), 40-44% kcal from carbohydrate, and 20% kcal from protein. Patient caloric intake will be calculated according to the Recommended Daily Allowance (RDA) for age. Supplementation of omega 3, the dose of omega-3 fatty acids will be determined by baseline weight (\<40 kg-450 mg/day, 40-60 kg-900 mg/day, \>60 kg-1300 mg/day). Patients will also receive daily doses of Ursodeoxycholic acid (UCD) Ursofalk) in a dose of 20 mg/Kg/day in two divided doses depending on their body weight for 12 weeks. Patients will participate in a 12-week exercise program for 30-45 min/day for 3 days/week in the first 2 weeks and for 60 min/day for 4-5 days/week thereafter.
- interventionNames
- Drug: Ursodeoxycholic Acid 250 Mg Oral Capsule
- Dietary Supplement: Omega -3 fatty acids
- Behavioral: Physical exercise
- Behavioral: Mediterrenean diet
- type
- ACTIVE_COMPARATOR
- label
- Arm(2)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Children aged between 5-18 years, including: * Population P1: N=65 overweight (BMI between 85th \& 94th centile) and obese children (BMI = or \> 95th centile) at-risk of NAFLD * Population P2: N=65 children on maintenance therapy (High Dose Methotrexate 2.5 or 5 mg according to risk level, every other week for 4 doses and daily 6-Mercaptopurine tab. 50 mg/m2/day for 56 days) for Acute Lymphoblastic Leukemia, at risk of chemotherapy induced steatohepatitis. * Population P3: N=65 control healthy children matched for gender and age with P1\&2. Exclusion Criteria: * Conditions that could interfere with measured labs (acute/chronic hemolysis, acute hepatitis, extra hepatic cholestasis, systemic inflammatory response).
References
Publications (0)
Data not yet available