Hepatoprotective Measures for Children at High Risk of NAFLD

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. 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

• Non Alcoholic Fatty Liver Diseases (NAFLD)
• Obesity and Overweight
• Acute 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.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Principal Investigators

• Manal H El-Sayed, Professor of pediatrics · Ain Shams University-Faculty of Medicine-Pediatric Department

• Fatma SE Ebeid, Professor of pediatrics · Ain Shams University-Faculty of Medicine-Pediatric Department

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-19

Primary Completion

2025-05-31

Completion

2025-07-31

FDA Drug

Yes

Countries

• Egypt

Study Locations