Metabolic Dysfunction-Associated Steatoic Liver DiseasePhase 3MASLDNCT07863648
Vitamin E Versus Silymarin in Non Diabetic MASLD Patients
A Phase 3 study testing Vitamin E 800 IU/d and Silymarin 420 mg in people with Metabolic Dysfunction-Associated Steatoic Liver Disease, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatoic Liver Disease
- What is being tested?
- Vitamin E 800 IU/d and Silymarin 420 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Oct 2026to 1 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Cirrhosis (LSM >12 kPa),
- Decompensated liver disease,
- Other liver diseases, decompensated cirrhosis,
- Pregnancy, or
- use of vitamin E/silymarin within 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Evaluation of Vitamin E Versus Silymarin on Liver Through Modulation of mRNA Profiles, NLRP3 Inflammasome Signaling, and Oxidative Stress in Non Diabetic MASLD Patients
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.
Read the detailed description
To evaluate the efficacy of vitamin E (800 IU/day) versus silymarin (420 mg/day, divided TID) in modulating MASLD-associated mRNA expression, NLRP3 inflammasome levels, and MDA in adult patients with MASLD
- Being tested
- Vitamin E 800 IU/d, Silymarin 420 mg, Placebo
- Keywords
- MDA, TGF-β1, NLRP3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E 800 IU/dDrug
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 mgDrug
Participants in Silymarin Group will receive oral silymarin at dose of 420 mg/d for a total duration of 24 weeks
PlaceboDrug
participants in Placebo Group will receive an oral placebo capsule, identical in appearance to the active interventions once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E Group | Active comparator | Participants in vitamin E group will receive vitamin E 800 IU/day for 24 weeks Receives: Drug: Vitamin E 800 IU/d |
| Silymarin Group | Active comparator | Participants in Silymarin group will receive silymarin 420 mg/d for 24 weeks Receives: Drug: Silymarin 420 mg |
| Placebo Group | Placebo comparator | Participants in Placebo group will receive matching placebo for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA Expression for inflammasome activity
TGF-β1 and IL-1β
Measured: 24 weeks
Oxidative stress markers
MDA
Measured: 24 weeks
NLRP3 inflammasome activation
NLRP3 protein
Measured: 24 weeks
Secondary outcomes (1)
Liver enzymes
ALT/ AST
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start16 Oct 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatoic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: vitamin E, silymarin, or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mahmoud El-Khodary, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863648
- Sponsor's protocol ID
- 36265PR129/6/26
- Acronym
- MASLD
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Evaluation of Vitamin E Versus Silymarin on Liver Through Modulation of mRNA Profiles, NLRP3 Inflammasome Signaling, and Oxidative Stress in Non Diabetic MASLD Patients
- ClinicalTrials.gov ID
- NCT07863648
- Acronym / sponsor ID
- MASLD / 36265PR129/6/26
- Keywords
- MDA, TGF-β1, NLRP3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 16 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To evaluate the efficacy of vitamin E (800 IU/day) versus silymarin (420 mg/day, divided TID) in modulating MASLD-associated mRNA expression, NLRP3 inflammasome levels, and MDA in adult patients with MASLD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: vitamin E, silymarin, or placebo.
| Arm | Type | Receives |
|---|---|---|
| Vitamin E Group | Active comparator | Drug: Vitamin E 800 IU/dParticipants in vitamin E group will receive vitamin E 800 IU/day for 24 weeks |
| Silymarin Group | Active comparator | Drug: Silymarin 420 mgParticipants in Silymarin group will receive silymarin 420 mg/d for 24 weeks |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants in Placebo group will receive matching placebo for 24 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- Cirrhosis (LSM >12 kPa),
- Decompensated liver disease,
- Other liver diseases, decompensated cirrhosis,
- Pregnancy, or
- use of vitamin E/silymarin within 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E 800 IU/dParticipants in Vitamin E Group will receive oral vitamin E at dose of 800 IU/d for a total duration of 24 weeks | Drug | Vitamin E Group |
| Silymarin 420 mgParticipants in Silymarin Group will receive oral silymarin at dose of 420 mg/d for a total duration of 24 weeks | Drug | Silymarin Group |
| Placeboparticipants in Placebo Group will receive an oral placebo capsule, identical in appearance to the active interventions once daily for 24 weeks | Drug | Placebo Group |
Primary outcome
mRNA Expression for inflammasome activity
Time frame: 24 weeks
TGF-β1 and IL-1β
Oxidative stress markers
Time frame: 24 weeks
MDA
NLRP3 inflammasome activation
Time frame: 24 weeks
NLRP3 protein
1 secondary outcome
Liver enzymes
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Data is available with the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin E 800 IU/d and Silymarin 420 mg in people with Metabolic Dysfunction-Associated Steatoic Liver Disease, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha M El-Khodary, Associate Professor (+01283950155, noha_mahmoud@pharm.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA Expression for inflammasome activity (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.