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Effect of Melatonin in Prevention of Vancomycin-Induced Nephrotoxicity

Comparison of the Effectiveness of Melatonin Versus Placebo in Prevention of Vancomycin-Induced Nephrotoxicity in Hospitalized Patients: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241126063867N1
Enrollment
90
Registered
2025-01-02
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Drug-induced acute kidney injury. Acute kidney failure, unspecified

Interventions

Intervention 1: Intervention group: Patients in the intervention group will receive intravenous vancomycin along with oral melatonin. Vancomycin will be administered with a loading dose of 20 mg/kg ba

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years old Receiving vancomycin for at least 4 days Baseline serum creatinine clearance above 30 mL/min at the start of treatment Hospitalized in infectious diseases ward of Shahid Sadoughi Hospital of Yazd Informed consent to participate in the study

Exclusion criteria

Exclusion criteria: History of hypersensitivity to vancomycin or melatonin Concurrent use of nephrotoxic drugs including amphotericin B, aminoglycosides, contrast media and NSAIDs Concurrent use of other antioxidants including vitamin C, vitamin E and N-acetylcysteine Body mass index greater than or equal to 30 Receipt of vancomycin within the past 20 days

Design outcomes

Primary

MeasureTime frame
Mean serum creatinine level. Timepoint: Day 1 (baseline), Day 2, Day 3, Day 4, Day 5. Method of measurement: autoanalyzer.

Secondary

MeasureTime frame
Changes in GFR. Timepoint: Daily from study initiation up to 14 days. Method of measurement: Cockcroft-Gault formula.;Incidence of acute kidney injury. Timepoint: Daily assessment using RIFLE criteria until study completion. Method of measurement: Assessment using RIFLE criteria (Risk, Injury, Failure, Loss, End-stage kidney disease).;Drug adverse effects:. Timepoint: Daily from study initiation up to 14 days. Method of measurement: Assessment using Naranjo scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Amin Salehi Abarqoui

Yazd University of Medical Sciences

mah3a3ty@gmail.com+98 917 492 5286

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026