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IRCT20170202032367N9 IRCT 2023-08-11 Tehran University of Medical Sciences The effects of melatonin supplementation on oxidative stress, inflammatory biomarkers and lipid profile in diabetic patients with chronic kidney disease- a randomized trial The effects of melatonin supplementation on oxidative stress, inflammatory biomarkers and lipid profile in diabetic patients with chronic kidney disease- a randomized trial 2023-09-23 anticipated 48 Complete https://irct.ir/trial/70709 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 48 Patients were randomly assigned to each group (A/B) using block randomization stratified based on age (category1:under 30/category2:above 30) and gender (male/female). Random sequences were generated by creating a blocked randomization list from www.sealedenvelope.com in 12 blocks with a size of 4. Treatment allocation was masked from participants, study personnel, and outcome assessors and was concealed in sequentially numbered, sealed, opaque envelopes. Patients were randomly assigned into two groups in a 1:1 ratio, Blinding description: Due to the fact that the placebo capsule is similar to melatonin in terms of appearance, color, smell, taste and shape, the people participating in the experiment will not be able to differentiate between the melatonin capsule and the placebo. Blinding of the researcher will be done through the codes included in the packaging of the supplements. 3 Kidney disease in the stage before dialysis (stage 3 and 4). 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 intake. Then, by using a general questionnaire, information about age, gender, socioeconomic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements, and the duration of the disease will be taken from all people. At the beginning of the study and at the end of the fifth and tenth weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food recall , which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the intervention group will receive 10 mg melatonin supplement (Karen company) in the form of 2, 5 mg supplements per day. Intervention 2: Control group: 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 intake. Then, by using a general questionnaire, information about age, gender, socioeconomic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements, and the duration of the disease will be taken from all people. At the beginning of the study and at the end of the fifth and tenth weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food recall , which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the control group will receive 2 placebo capsules, which are similar to melatonin in terms of appearance, color, smell, taste and shape, for 10 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Hossien Imani
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 +9821889900285 h_imani@sina.tums.ac.ir Tehran University of Medical Sciences scientific Hossien Imani
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1416643931 0098 21 889900285 h_imani@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 25 years 65 years Both 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 N18.9 Chronic kidney disease, unspecified Rehabilitation Placebo 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 intake. Then, by using a general questionnaire, information about age, gender, socioeconomic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements, and the duration of the disease will be taken from all people. At the beginning of the study and at the end of the fifth and tenth weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food recall , which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the intervention group will receive 10 mg melatonin supplement (Karen company) in the form of 2, 5 mg supplements per day. Control group: 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 intake. Then, by using a general questionnaire, information about age, gender, socioeconomic status, education level, history of diseases and hospitalization, surgery and history of taking medicines, supplements, and the duration of the disease will be taken from all people. At the beginning of the study and at the end of the fifth and tenth weeks of the study, in order to investigate the intervening factors of the diet, 24-hour food recall , which includes two non-holiday days and one holiday day, will be taken from the patients through interviews. At the end of the run-in period, people in the control group will receive 2 placebo capsules, which are similar to melatonin in terms of appearance, color, smell, taste and shape, for 10 weeks. 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. 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). Tehran University of Medical Sciences Approved 2023-07-23 Ethics Committee of Tehran University of Medical Sciences Faculty of Nutrition Sciences and Dietetics, Hojat Dost Alley, Khanaderi, Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)