Evaluation of melatonin efficacy in prevention of vancomycin induced nephrotoxicity

Evaluation of melatonin tablet efficacy in prevention of vancomycin induced nephrotoxicity in hospitalized patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200408046990N18

Enrollment

140

Registered

2025-06-02

Start date

2025-06-05

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Patients treated with vancomycin. Bacterial infection of unspecified site

Interventions

Intervention 1: Intervention group: The intervention group will receive melatonin tablets at a dose of 5 mg twice a day for 14 days or until vancomycin is discontinued. Intervention 2: Control group:

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 60 Signing a written informed consent No simultaneous use of fluvoxamine and other nephrotoxic drugs

Exclusion criteria

Exclusion criteria: Patient's unwillingness to continue the study Allergy history to melatonin Glomerular filtration rate less than 60 ml/min Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Acute Kidney Injury (increase of 0.3 mg/dl in creatinine for two consecutive days). Timepoint: Measurement of serum creatinine levels at the beginning of the study (before the start of the intervention) and on days 3, 7, 10 and 14 of melatonin administration. Method of measurement: Measurement of serum creatinine level and blood urea nitrogen level and evaluation of acute kidney injury based on Acute Kidney Injury Network/Kidney Disease: Improving Global Outcomes criteria.;Serum creatinine and BUN levels. Timepoint: Measurement of serum creatinine and BUN levels at the beginning of the study (before the start of the intervention) and on days 3, 7, 10 and 14 of melatonin administration. Method of measurement: Serum level measurement by the laboratory.;Serum cystatin C level. Timepoint: On days 0, 3, and 7. Method of measurement: Serum level measurement.	—

Measure

Time frame

Acute Kidney Injury (increase of 0.3 mg/dl in creatinine for two consecutive days). Timepoint: Measurement of serum creatinine levels at the beginning of the study (before the start of the intervention) and on days 3, 7, 10 and 14 of melatonin administration. Method of measurement: Measurement of serum creatinine level and blood urea nitrogen level and evaluation of acute kidney injury based on Acute Kidney Injury Network/Kidney Disease: Improving Global Outcomes criteria.;Serum creatinine and BUN levels. Timepoint: Measurement of serum creatinine and BUN levels at the beginning of the study (before the start of the intervention) and on days 3, 7, 10 and 14 of melatonin administration. Method of measurement: Serum level measurement by the laboratory.;Serum cystatin C level. Timepoint: On days 0, 3, and 7. Method of measurement: Serum level measurement.

—

Secondary

Measure	Time frame
Malondialdehyde (MDA) and glutathione (GSH) levels. Timepoint: On days 0 and 7. Method of measurement: Serum level measurement.;Vital Signs. Timepoint: every day. Method of measurement: clinical examination.;Vancomycin trough concentration. Timepoint: On the third day of treatment before vancomycin infusion. Method of measurement: Serum level measurement.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepideh Elyasi

Mashhad University of Medical Sciences

elyasis@mums.ac.ir+98 51 3180 1588

Outcome results

None listed

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