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Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.
Sponsor: Ain Shams University
Summary
Background: Vancomycin, a key antibiotic for MRSA infections, frequently causes nephrotoxicity (kidney damage) via oxidative stress, especially at the higher doses and longer durations now recommended. Antioxidants like rutin and ascorbic acid (vitamin C) have shown promise in reducing this toxicity in preclinical and limited human studies, but no trial has tested them together. Aim: Evaluate whether combined rutin + ascorbic acid supplementation reduces the incidence of vancomycin-induced nephrotoxicity (VAN) in adult patients, compared to ascorbic acid alone and a control group. Design: Prospective, open-label, randomized controlled, three-arm clinical trial; 120 adult patients recruited from Internal Medicine departments at Ain Shams University Hospital. Population: Adults (≥18) receiving vancomycin for ≥7 days for MRSA infections, without prior kidney injury, proteinuria/hematuria, or other antioxidant/nephrotoxic drug use. Outcomes: Primary: Changes in serum creatinine, NGAL, BUN, creatinine clearance, BUN/creatinine ratio Secondary: Serum potassium/sodium, CRP, total leukocyte count, procalcitonin
Official title: Impact of Rutin and Ascorbic Acid in Reducing The Incidence of Vancomycin Indueced Nephrotoxicity in Adult Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-10-01
Completion Date
2026-12-30
Last Updated
2026-10-14
Healthy Volunteers
Yes
Conditions
Interventions
Rutin + Ascorbic Acid (RUTA C60®)
Rutin 60 mg combined with ascorbic acid 160 mg, administered orally as two tablets three times daily. Each dose will be given half an hour before the scheduled vancomycin infusion, continued throughout the 14-day study period. The combination is intended to reduce oxidative stress and inflammation associated with vancomycin-induced nephrotoxicity through the antioxidant properties of both agents.
Ascorbic Acid (C-Retard®)
Ascorbic acid 500 mg, administered orally as one sustained-release capsule twice daily. Each dose will be given half an hour before the scheduled vancomycin infusion, continued throughout the 14-day study period. Ascorbic acid is intended to act as an antioxidant, scavenging reactive oxygen species generated by vancomycin therapy to mitigate renal tubular injury.
Locations (1)
Ain Shams University Hospitals
Cairo, Cairo Governorate, Egypt