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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: NAFLD
• Intervention / Treatment: Drug: Rutin + Vitamin C; Drug: Vitamin C 500mg; Behavioral: Lifestyle Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shaimaa s Bashoaib, master; Phone Number: +201091316484; Email: shaimaa.salem22@pharma.asu.edu.eg
• Study Contact Backup: Name: Sarah M Fahmy, Asso Prof; Phone Number: +201127666522; Email: sarah.farid@pharma.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • National Hepatology and Tropical Medicine Research Institute (NHTMRI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ruta C group; 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).	Drug: Rutin + Vitamin 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.; Other Names: Ruta C
Experimental: Vitamin C group; Drug: Vitamin C - Oral capsules, 500 mg, twice daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise).	Drug: Vitamin C 500mg; Type: Drug (Single agent) Oral administration of Vitamin C 500 mg, taken twice daily for 12 weeks; Other Names: C-Retard
Experimental: Control group; Behavioral: Lifestyle Intervention - Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, and structured exercise program for 12 weeks	Behavioral: Lifestyle Intervention; Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, plus structured exercise program for 12 weeks.; Other Names: diet and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12.	Serum TNF-α, a key biomarker of inflammation in MASLD	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Sara M Zaki, Professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Diet, Food, and Nutrition; Physiological Phenomena; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Nutritional Physiological Phenomena; Benzopyrans; Flavonols; Flavonoids; Chromones; Ascorbic Acid; Exercise; Diet; Rutin
• Other Study ID Numbers: REC Approval Number: REC # 414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No