Evaluation of the melatonin effect on proteinuria, inflammatory and oxidative stress factors in patients with chronic kidney disease

Evaluation of the melatonin effect on proteinuria, inflammatory and oxidative stress factors in patients with chronic kidney disease, a randomized, double-blind, placebo-controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160412027346N12

Enrollment

Registered

2025-06-20

Start date

2025-01-20

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

Chronic Kidney Disease. Chronic kidney disease (CKD)

Interventions

Intervention 1: Intervention group:44 patients in the intervention group receive melatonin (manufactured by Razak Pharmaceutical Company) at a dose of 6 mg daily at night before going to bed. It will

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who wish to sign the informed consent form to participate in the study Patients who are 18 years old and older Patients with chronic kidney disease who have a Glomerular filtration rate (GFR) of less than 60 Patients who have proteinuria less than 3 grams per 24 hours Patients who agree not to participate in another research study before the completion of this study

Exclusion criteria

Exclusion criteria: Patients receiving proteinuria-lowering drugs except statins, Angiotensin-converting enzyme (ACEIs), Angiotensin receptor blockers (ARBs) Dialysis patients, patients with active infection, malignancy, night shift, pregnancy and breastfeeding, smoking, liver cirrhosis, taking antidepressants and antipsychotics and anticonvulsants, sensitivity to melatonin

Design outcomes

Primary

Measure	Time frame
Proteinuria in 24 hours urine (Measurement of urine creatinine and protein). Timepoint: The beginning of the study and 3 months later. Method of measurement: 24-hour urine sample analysis.;Malondialdehyde. Timepoint: The beginning of the study and 3 months later. Method of measurement: By fluorometric method.;Interleukin 1 beta. Timepoint: The beginning of the study and 3 months later. Method of measurement: Examining the blood sample with a special laboratory kit.	—

Measure

Time frame

Proteinuria in 24 hours urine (Measurement of urine creatinine and protein). Timepoint: The beginning of the study and 3 months later. Method of measurement: 24-hour urine sample analysis.;Malondialdehyde. Timepoint: The beginning of the study and 3 months later. Method of measurement: By fluorometric method.;Interleukin 1 beta. Timepoint: The beginning of the study and 3 months later. Method of measurement: Examining the blood sample with a special laboratory kit.

—

Secondary

Measure	Time frame
Serum creatinine. Timepoint: The beginning of the study and three months later. Method of measurement: Blood sample.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shadi Ziaei

Shahid Beheshti University of Medical Sciences

shadi_z73@yahoo.com+98 21 8812 0632

Outcome results

None listed

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