The effects of melatonin supplementation on oxidative stress, inflammatory biomarkers and lipid profile in diabetic patients with chronic kidney disease- a randomized trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170202032367N9

Enrollment

Registered

2023-08-11

Start date

2023-09-23

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Kidney disease in the stage before dialysis (stage 3 and 4). Chronic kidney disease, unspecified

Interventions

Intervention 1: Intervention group: Before starting the main intervention, all the selected people enter the Run-in period for two weeks, to collect complete information about the patients' food intak

Eligibility

Sex/Gender

All

Age

25 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age above 25 and below 65 years Having CKD in the stage before dialysis (stage 3 to 4) which is diagnosed based on laboratory findings and the opinion of a nephrologist. Body mass index above 20 and below 30 kg/m2 Willingness to cooperate in this study

Exclusion criteria

Exclusion criteria: Having CKD due to autoimmune diseases and glomerulonephritis Blood pressure higher than 100/160 mmHg Pregnancy or intention to become pregnant within the next 6 months, breastfeeding Infectious, inflammatory diseases, thyroid gland disorders, thrombocytopenia Being under enteral and parenteral nutritional support Taking omega-3 supplements and antioxidant supplements (vitamin E, vitamin C, vitamin B6, selenium, zinc and beta-carotene separately) from 3 months before entering the study Taking glucocorticoid drugs with a dose of more than 5 mg, antibiotics, fluoxamin, non-steroidal anti-inflammatory drugs, warfarin smoking People who have night shift jobs

Design outcomes

Primary

Measure	Time frame
Serum levels of oxidative stress markers (TAC, TOS , MDA). Timepoint: Before the intervention and 10 weeks later. Method of measurement: Pars azmoon kit and spectrophotometry method.;Serum levels of inflammatory markers (hs-CRP, IL-6). Timepoint: Before the intervention and 10 weeks later. Method of measurement: ELISA kit.	—

Secondary

Measure	Time frame
Serum levels of lipid parameters (T.G, T.C, LDL, HDL). Timepoint: Before the intervention and 10 weeks later. Method of measurement: Pars azmoon kit and spectrophotometry method.;Serum levels of renal indicators (Cr, BUN, uric acid). Timepoint: Before the intervention and 10 weeks later. Method of measurement: Calorimetric detection kits.;Systolic and diastolic blood pressure. Timepoint: Before the intervention and 10 weeks later. Method of measurement: Sphygmomanometer and calibrated stethoscope.;Serum levels of fasting blood sugar and serum insulin. Timepoint: Before the intervention and 10 weeks later. Method of measurement: Diagnostic kits.;Serum phosphorus level. Timepoint: Before the intervention and 10 weeks later. Method of measurement: Calorimetric detection kit.;Sleep quality score. Timepoint: Before the intervention and 10 weeks later. Method of measurement: Sleep quality questionnaire (PSQI).;Carbohydrate, protein, fat and fiber intake. Timepoint: Before the intervention and 5 and10 weeks later. Method of measurement: 24-hour dietary recall (24HR).	—

Measure

Time frame

Serum levels of lipid parameters (T.G, T.C, LDL, HDL). Timepoint: Before the intervention and 10 weeks later. Method of measurement: Pars azmoon kit and spectrophotometry method.;Serum levels of renal indicators (Cr, BUN, uric acid). Timepoint: Before the intervention and 10 weeks later. Method of measurement: Calorimetric detection kits.;Systolic and diastolic blood pressure. Timepoint: Before the intervention and 10 weeks later. Method of measurement: Sphygmomanometer and calibrated stethoscope.;Serum levels of fasting blood sugar and serum insulin. Timepoint: Before the intervention and 10 weeks later. Method of measurement: Diagnostic kits.;Serum phosphorus level. Timepoint: Before the intervention and 10 weeks later. Method of measurement: Calorimetric detection kit.;Sleep quality score. Timepoint: Before the intervention and 10 weeks later. Method of measurement: Sleep quality questionnaire (PSQI).;Carbohydrate, protein, fat and fiber intake. Timepoint: Before the intervention and 5 and10 weeks later. Method of measurement: 24-hour dietary recall (24HR).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossien Imani

Tehran University of Medical Sciences

h_imani@sina.tums.ac.ir+9821889900285

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026