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Evaluation of the Effect of Melatonin on the Kidney

Investigating the nephroprotective effect of melatonin on nephrotoxicity caused by colistin

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250303064922N1
Enrollment
146
Registered
2025-03-13
Start date
2025-04-09
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

Nephrotoxicity.

Interventions

Intervention 1: Intervention group receive two 10 mg melatonin tablets every night for 14 days during colistin therapy. Intervention 2: Control group receive two placebo tablets manufactured by Jalino

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who are admitted to the intensive care unit They are over 18 years old They receive colistin at a dose of 9 million units per day Men have creatinine levels below 1.5 mg/dL, and women have creatinine levels below 1.3 mg/dL They have a creatinine clearance above 60

Exclusion criteria

Exclusion criteria: Patients who did not receive the full dose of colistin over two weeks Patients who did not receive the full two weeks of melatonin and colistin Patients who were using nephrotoxic drugs, including aminoglycosides and vancomycin Patients who have underlying conditions such as diabetes and hypertension Patients with neurological conditions or conditions that cause changes in urine volume Patients with bleeding and dehydration

Design outcomes

Primary

MeasureTime frame
Urine volume. Timepoint: Daily. Method of measurement: Container for measuring the volume of liquids.;Serum creatinine. Timepoint: Daily. Method of measurement: Serum level measurement by the laboratory.;Blood urea nitrogen. Timepoint: Daily. Method of measurement: Serum level measurement by the laboratory.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh sanaei

Karaj University of Medical Sciences

fatemesanaei1374@gmail.com+98 26 3442 7001

Outcome results

None listed

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