Rutin and Vitamin C in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

NCT07310407 — Phase 2, Not yet recruiting, 120 participants, Ain Shams University

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Evaluation of the Effect of Rutin and Vitamin C in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

Registry	NCT07310407
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	120 (Estimated)
Sponsor	Ain Shams University (Other)
Conditions	NAFLD
Interventions	Rutin + Vitamin C, Vitamin C 500mg, Lifestyle Intervention (Drug, behavioral)
Dates	start 2026-01-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-03-01 (estimated), first posted 2025-12-30, last updated 2025-12-30
Locations	1 site in Egypt

-Summary

evaluate the combined effects of Rutin and Vitamin C versus Vitamin C alone on selected oxidative stress markers, inflammation, hepatic steatosis regression, and associated metabolic parameters in patients with MASLD

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+Detailed description

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a common liver disorder with risks of progression to fibrosis, cirrhosis, and hepatocellular carcinoma.

Its global prevalence is high, driven by oxidative stress and impaired antioxidant defenses, while no approved pharmacological treatments currently exist. Nutritional agents such as vitamin C and rutin show promise in improving liver function and reducing oxidative damage.

This study will evaluate their combined effects in addressing MASLD's multifactorial pathology.

+Arms and interventions

Arm	Type	Interventions	Description
Ruta C group	Experimental	Drug: Rutin + Vitamin C	Drug: Rutin + Vitamin C - Oral, two tablets containing 60 mg Rutin + 160 mg Vitamin C, three times daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise).
Vitamin C group	Experimental	Drug: Vitamin C 500mg	Drug: Vitamin C - Oral capsules, 500 mg, twice daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise).
Control group	Experimental	Behavioral: Lifestyle Intervention	Behavioral: Lifestyle Intervention - Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, and structured exercise program for 12 weeks

Rutin + Vitamin C (Drug), also known as Ruta C: Type: Drug (Combination therapy) Details: Oral administration of two tablets containing 60 mg Rutin + 160 mg Vitamin C, taken three times daily for 12 weeks.
Vitamin C 500mg (Drug), also known as C-Retard: Type: Drug (Single agent) Oral administration of Vitamin C 500 mg, taken twice daily for 12 weeks
Lifestyle Intervention (Behavioral), also known as diet and exercise: Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, plus structured exercise program for 12 weeks.

+Outcome measures

Primary outcomes

• Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12. [12 weeks]: Serum TNF-α, a key biomarker of inflammation in MASLD

Secondary outcomes

• Change in serum malondialdehyde (MDA) levels from baseline to week 12. [12 weeks]: Malondialdehyde (MDA) is a well-established biomarker of oxidative stress in MASLD, reflecting lipid peroxidation and liver injury.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Confirmed diagnosis of Metabolic-Associated Steatotic Liver Disease (MASLD).

Exclusion Criteria:

* HCV infection.
* HBV infection.
* Patients with a history of significant alcohol consumption.
* Autoimmune hepatitis.
* Celiac disease (CD).
* Wilson's disease (WD).
* Haemochromatosis.
* Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, steroids and immunosuppressive agents, oral contraceptive pills, or drugs that can affect liver profile.
* Hypo or hyper thyroidism.
* Bypass surgeries.
* TPN (Total Parenteral Nutrition).
* Pregnant individuals or patients planning to become pregnant.

+Locations (1)

Facility	City	Country	Status
National Hepatology and Tropical Medicine Research Institute (NHTMRI)	Cairo	Egypt

+Investigators

Sara M Zaki, Professor, Study director, Ain Shams University