Status:
ACTIVE_NOT_RECRUITING
Hepatoprotective Measures for Children at High Risk of NAFLD
Lead Sponsor:
Ain Shams University
Conditions:
Non Alcoholic Fatty Liver Diseases (NAFLD)
Obesity and Overweight
Eligibility:
All Genders
5-18 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Nonalcoholic fatty liver disease (NAFLD), defined as abnormal hepatic accumulation of macrovesicular fat in the absence of other etiologies. NAFLD is becoming increasingly prevalent in the pediatric p...
Eligibility Criteria
Inclusion
- 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
- Conditions that could interfere with measured labs (acute/chronic hemolysis, acute hepatitis, extra hepatic cholestasis, systemic inflammatory response).
Key Trial Info
Start Date :
November 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06918080
Start Date
November 19 2023
End Date
July 1 2025
Last Update
April 9 2025
Active Locations (2)
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1
Ain Shams University
Cairo, Egypt, 11566
2
Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC)
Cairo, Egypt, 11566