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

Ain Shams University

Status and phase: Not yet enrolling; Phase 2

Conditions: NAFLD

Treatments: Drug: Vitamin C 500mg; Drug: Rutin + Vitamin C; Behavioral: Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07310407

REC Approval Number: REC # 414

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Ruta C group

Experimental group

Description:

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).

Treatment:

Drug: Rutin + Vitamin C

Vitamin C group

Experimental group

Description:

Drug: Vitamin C - Oral capsules, 500 mg, twice daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise).

Treatment:

Drug: Vitamin C 500mg

Control group

Experimental group

Description:

Behavioral: Lifestyle Intervention - Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, and structured exercise program for 12 weeks

Treatment:

Behavioral: Lifestyle Intervention