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Vitamin E Versus Silymarin in Non Diabetic MASLD Patients

ConditionMetabolic Dysfunction-Associated Steatoic Liver Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKafrelsheikh University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adults (18-65 y),

Diagnosed with MASLD (CAP ≥248 dB/m on FibroScan, ALT >40 IU/L),

Non-diabetic (HbA1c <6.5%, fasting glucose <126 mg/dL),

BMI 25-40 kg/m²,

Disqualifiers

Cirrhosis (LSM >12 kPa),

Decompensated liver disease,

Other liver diseases, decompensated cirrhosis,

Pregnancy, or

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin E 800 IU/d

    Drug

    Participants in Vitamin E Group will receive oral vitamin E at dose of 800 IU/d for a total duration of 24 weeks

  • Silymarin 420 mg

    Drug

    Participants in Silymarin Group will receive oral silymarin at dose of 420 mg/d for a total duration of 24 weeks

  • Placebo

    Drug

    participants in Placebo Group will receive an oral placebo capsule, identical in appearance to the active interventions once daily for 24 weeks

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Vitamin E GroupActive comparator 1 intervention
Group B: Silymarin GroupActive comparator 1 intervention
Group C: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

mRNA Expression for inflammasome activity

TGF-β1 and IL-1β

Time frame
24 weeks
2

Oxidative stress markers

MDA

Time frame
24 weeks
3

NLRP3 inflammasome activation

NLRP3 protein

Time frame
24 weeks

Secondary outcomes

1

Liver enzymes

ALT/ AST

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: