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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07310407

Enrollment

120

Registered

2025-12-30

Start date

2026-01-01

Completion date

2027-03-01

Last updated

2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD

Brief 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

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.

Interventions

DRUGRutin + 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.

DRUGVitamin C 500mg

Type: Drug (Single agent) Oral administration of Vitamin C 500 mg, taken twice daily for 12 weeks

BEHAVIORALLifestyle Intervention

Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, plus structured exercise program for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
• 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

Measure	Time frame	Description
• 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.

Countries

Egypt

Contacts

Primary ContactShaimaa s Bashoaib, master

shaimaa.salem22@pharma.asu.edu.eg+201091316484

Backup ContactSarah M Fahmy, Asso Prof

sarah.farid@pharma.asu.edu.eg+201127666522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026