Hepatoprotective Measures for Children at High Risk of NAFLD

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 19, 2023

Primary Completion Date

May 31, 2025

Study Completion Date

July 31, 2025

Conditions
Non Alcoholic Fatty Liver Diseases (NAFLD)Obesity and OverweightAcute Lymphoblastic Leukemia
Interventions
DRUG

Ursodeoxycholic Acid 250 Mg Oral Capsule

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 will be assigned to arm(1)

DIETARY_SUPPLEMENT

Omega -3 fatty acids

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) will be assigned to children in arm (1). Side effect such as gastrointestinal upset and allergy will be monitored, compliance will be monitored by weekly phone call

BEHAVIORAL

Physical exercise

Patients assigned to arm (1) will participate in a 12-week exercise program for 30-45 min/day for 3 days/week. in the first two weeks and for 60 min/day for 4-5 days/week in the following weeks

BEHAVIORAL

Mediterrenean diet

"Patients in arm (1) 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.( Plaz et al., 2019) Patient caloric intake will be calculated according to the Recommended Daily Allowance (RDA) for age.~Compliance to the MD will be assessed in all patients using the KIDMED index at 4 ,8 and 12 weeks.Those who prove to be non-compliant will be excluded from the study."

BEHAVIORAL

Diet according to NASPGHAN guidelines

Patients in arm (2) will receive lifestyle modification according to NASPGHAN Clinical Guidelines for the treatment of NAFLD in Children. Patients will follow healthy and well-balanced diet. Patient caloric intake will be calculated according to the Recommended Daily Allowance (RDA) for age, with avoidance of sugar-sweetened beverages, moderate- to high-intensity exercise daily will be encouraged, and screen time will be limited to less than 2 hours.

Trial Locations (2)

11566

Ain Shams University, Cairo

Faculty of Medicine Ain Shams Research Institute- Clinical Research Center (MASRI-CRC), Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT06918080 - Hepatoprotective Measures for Children at High Risk of NAFLD | Biotech Hunter | Biotech Hunter