Vitamin E Versus Silymarin in Non Diabetic MASLD Patients

NCT07863648 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 36265PR129/6/26
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Keywords

MDA; TGF-β1; NLRP3

Outcome Measures

Primary Outcomes (3)

• mRNA Expression for inflammasome activity

  TGF-β1 and IL-1β

  24 weeks

• Oxidative stress markers

  MDA

  24 weeks

• NLRP3 inflammasome activation

  NLRP3 protein

  24 weeks

Secondary Outcomes (1)

• Liver enzymes

  24 weeks

Study Arms (3)

Vitamin E Group

ACTIVE COMPARATOR

Participants in vitamin E group will receive vitamin E 800 IU/day for 24 weeks

Drug: Vitamin E 800 IU/d

Silymarin Group

ACTIVE COMPARATOR

Participants in Silymarin group will receive silymarin 420 mg/d for 24 weeks

Drug: Silymarin 420 mg

Placebo Group

PLACEBO COMPARATOR

Participants in Placebo group will receive matching placebo for 24 weeks

Drug: Placebo

Interventions

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

Vitamin E Group

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

Silymarin Group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• No alcohol (\>20 g/d women, \>30 g/d men).

You may not qualify if:

• Cirrhosis (LSM \>12 kPa),
• Decompensated liver disease,
• Other liver diseases, decompensated cirrhosis,
• Pregnancy, or
• use of vitamin E/silymarin within 3 months.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Medicine

Tanta, 31511, Egypt

Location

MeSH Terms

Interventions

Vitamin E; Silymarin

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavonolignans; Flavonoids; Chromones

Central Study Contacts

Noha Mahmoud El-Khodary, Associate Professor

CONTACT

+01283950155; noha_mahmoud@pharm.kfs.edu.eg

Amr Y. Zakaria, Lecturer

CONTACT

+01127744748; ahamza@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Placebo group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to one of three parallel groups: vitamin E, silymarin, or placebo.

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 7, 2026
• Study Start (Estimated): October 16, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 7, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)