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IRCT20200527047584N2 IRCT 2020-07-21 Kashan University of Medical Sciences Evaluation of the effect of melatonin supplementation on vascular diseases in patients with diabetic nephropathy Evaluation of the effect of melatonin supplementation on Carotid Intima-Media Thickness, pulse-wave velocity and serum levels of hs-CRP in patients with diabetic nephropathy 2020-04-20 anticipated 60 Complete https://irct.ir/trial/48709 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: After specifying the sample size, blocks of size 4 consisting of A and B letters are formed (6 blocks). Then, each of the blocks is numbered 1 to 6 and based on the selected numbers from random numbers table, we form a sequence of blocks, in which the letters A and B are located, and then randomly one of the letters are considered as the drug group and the other letter as the control group. This method is referred to as "Permuted Blocked Randomization", Blinding description: Patients, radiologists and technicians who calculate pulse wave velocity are unaware of patients' groups. 3 Diabetes. Intervention 1: Intervention group: melatonin 5 mg (from NUTRALab), 2 capsules daily (half hour before sleep) for 24 weeks. Intervention 2: Control group: placebo, 2 capsules daily (half hour before sleep) for 24 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 Non additional information
public Hamidreza Talari
Postal Code 81151/87159, Shahid Beheshti Hospital, Pezeshk Ave, Ravand Street
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0026 talari_hr@kaums.ac.ir Kashan University of Medical Sciences scientific Hamidreza Talari
Postal Code 81151/87159, Shahid Beheshti Hospital, Pezeshk Ave, Ravand Street
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 0026 talari_hr@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Approved diabetes Proteinuria > 500 miligram per day GFR between 15-89 mLit/min HbA1c < 7.2 Systolic blood pressure between 140-160 mmHg and Diastolic blood pressure between 90-100 mmHg 40 years 85 years Both Pregnant or Lactating Smoker or alcohol abuser Underlying diseases including cardiovascular diseases, cancer, autoimmune disorders and hypo or hyperthyroidism Using fluvoxamine or antioxidant drugs Urinary tract infection or other diseases that cause proteinuria Night worker E11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group: melatonin 5 mg (from NUTRALab), 2 capsules daily (half hour before sleep) for 24 weeks Control group: placebo, 2 capsules daily (half hour before sleep) for 24 weeks Carotid-femoral pulse wave velocity. Timepoint: Before intervention and 24 weeks after intervention. Method of measurement: Color doppler ultrasound. Carotid Intima-media thickness. Timepoint: Before intervention and 24 weeks after intervention. Method of measurement: Color doppler ultrasound. Hs-CRP level. Timepoint: before and 24 weeks after intervention. Method of measurement: Blood test. Kashan University of Medical Sciences Approved 2020-02-17 Ethics committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Ghotb Ravandi St Kashan Isfehan Iran (Islamic Republic of)