An interventional study of Rutin + Ascorbic Acid (RUTA C60®) and Ascorbic Acid (C-Retard®) in Nephrotoxicity and Acute Kidney Injuries, sponsored by Ain Shams University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention
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
Background \& Rationale Vancomycin is a key antibiotic against MRSA but causes nephrotoxicity in 5-25% of patients (up to 35% with concurrent aminoglycosides), largely via oxidative stress and reactive oxygen species that trigger renal cell apoptosis.
Risk rises with newer high-dose regimens (trough 15-20 mg/L), treatment >5 days, obesity, intermittent infusion, and co-administration with other nephrotoxins (e.g., piperacillin/tazobactam, flucloxacillin).
Antioxidants (N-acetylcysteine, vitamin E) have shown benefit; ascorbic acid and rutin individually have antioxidant/anti-inflammatory effects supported by prior human and animal studies, but no trial has tested the rutin + vitamin C combination specifically for preventing vancomycin nephrotoxicity - this is the gap the study addresses.
Aim of the study:
Evaluate whether rutin + ascorbic acid supplementation reduces vancomycin-induced nephrotoxicity (VAN) versus ascorbic acid alone and versus control.
Study Design:
Prospective, open-label, randomized controlled, three-arm trial Setting: Internal Medicine departments, Ain Shams University Hospital Sample size: 120 patients (40/arm), calculated via G*Power (effect size 0.3, α=0.05, power 80%, adjusted for dropout)
Groups:
Group 1 (Intervention) Vancomycin + Rutin 60mg/Vitamin C 160mg (RUTA C60®), 2 tablets TID, 30 min pre-dose
Group 2 (Intervention) Vancomycin + Vitamin C 500mg (C-Retard®), 1 capsule BID, 30 min pre-dose
Group 3 (control) Vancomycin alone Randomization: Computer-generated block randomization (block size 6); allocation concealed via sequentially numbered, opaque, sealed envelopes (SNOSE).
Eligibility Criteria:
Include: Adults ≥18, MRSA infection needing vancomycin ≥7 days, no concurrent antioxidants, no proteinuria/hematuria/prior AKI Exclude: Drug allergies, pregnancy/lactation, baseline S.cr ≥2mg/dL, concurrent nephrotoxins, urinary stones, upcoming contrast media exposure
Outcomes:
Primary: Serum creatinine, plasma NGAL, BUN, creatinine clearance (Cockcroft-Gault), BUN/creatinine ratio Secondary: Serum K⁺/Na⁺, CRP, total leukocyte count, procalcitonin
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients in this arm will receive vancomycin plus a fixed-dose combination of rutin 60 mg and ascorbic acid 160 mg (RUTA C60®), given as two tablets three times daily, administered half an hour before each vancomycin dose, for the duration of the 14-day study period.
Drug: Rutin + Ascorbic Acid (RUTA C60®)
Patients in this arm will receive vancomycin plus ascorbic acid 500 mg (C-Retard®), given as one capsule twice daily, administered half an hour before the vancomycin dose, for the duration of the 14-day study period.
Drug: Ascorbic Acid (C-Retard®)
Patients in this arm will receive vancomycin therapy alone, with no rutin or ascorbic acid supplementation, following standard dosing protocols for the duration of the 14-day study period.
Drug pages: Rutin · Ascorbic Acid
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.
Also known as: (RUTA C60®)
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.
Change in Serum Creatinine
Measurement of serum creatinine levels to detect changes indicative of vancomycin-induced nephrotoxicity across the three study groups.
Time frame: Daily, from baseline to Day 14
Change in Creatinine Clearance
Creatinine clearance calculated using the Cockcroft-Gault equation (adjusted for body weight/BMI) to assess renal function changes during vancomycin therapy.
Time frame: Daily, from baseline to Day 14
Change in Blood Urea Nitrogen (BUN)
Measurement of BUN levels as a marker of renal function and potential nephrotoxic injury.
Time frame: Daily, from baseline to Day 14
Change in BUN/Creatinine Ratio
Calculated ratio of BUN to serum creatinine to further characterize the nature and severity of renal impairment.
Time frame: Daily, from baseline to Day 14
Change in Plasma NGAL (Neutrophil Gelatinase-Associated Lipocalin)
Plasma NGAL measured as an early biomarker of acute kidney tubular injury, prior to changes in serum creatinine.
Time frame: Baseline, Day 3, and Day 14 (end of study)
Change in Serum Potassium
Measurement of serum potassium levels to monitor electrolyte disturbances associated with renal impairment.
Time frame: Daily, from baseline to Day 14
Change in Serum Sodium
Measurement of serum sodium levels to monitor electrolyte disturbances associated with renal impairment.
Time frame: Daily, from baseline to Day 14
Change in C-Reactive Protein (CRP)
CRP levels measured to assess the systemic inflammatory response during vancomycin therapy and its modulation by antioxidant supplementation.
Time frame: Baseline and Day 14 (end of study)
Change in Procalcitonin
Procalcitonin measured as a marker of infection severity and inflammatory response.
Time frame: Baseline and Day 14 (end of study)
Change in Total Leukocyte Count
Total leukocyte count measured to assess infection status and inflammatory response over the treatment course.
Time frame: Baseline and Day 14 (end of study)
Plan to share: No — Individual participant data will not be shared, as this was not specified in the informed consent obtained from participants, and no data-sharing infrastructure or repository has been established for this single-center academic study.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Rutin · Ascorbic Acid