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NCT07863648
Vitamin E Versus Silymarin in Non Diabetic MASLD Patients
Conditions: MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 120
Sponsor: Kafrelsheikh University
Location: Faculty of Medicine Tanta
Summary
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), is a chronic liver condition marked by excessive fat buildup (steatosis) in liver cells, linked to at least one metabolic risk factor like obesity, type 2 diabetes, high blood lipids, or hypertension. Vitamin E serves as a recommended antioxidant therapy for select MASLD patients. It reduces liver inflammation markers such as ALT and AST, alongside benefits in steatosis and MASH resolution. Silymarin has clinical evidence supports its use as an adjunctive hepatoprotective agent due to antioxidant, anti-inflammatory, and antifibrotic effects.
Eligibility Criteria
Inclusion Criteria:
* Adults (18-65 y),
* Diagnosed with MASLD (CAP ≥248 dB/m on FibroScan, ALT \>40 IU/L),
* Non-diabetic (HbA1c \30 g/d men).
Exclusion Criteria:
* Cirrhosis (LSM \>12 kPa),
* Decompensated liver disease,
* Other liver diseases, decompensated cirrhosis,
* Pregnancy, or
* use of vitamin E/silymarin within 3 months.
Source: ClinicalTrials.gov (NCT07863648). StuddyBuddy aggregates publicly available trial information.