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IRCT20190407043194N1 IRCT 2019-08-14 Mashhad University of Medical Sciences The effect of Zinc and Selenium co-supplementation in T2D patients The Effect of Zinc and Selenium co-supplementations on blood glucose and inflammatory/antioxidant biomarkers in Type 2 Diabetes Mellitus patients 2019-05-05 anticipated 80 Complete https://irct.ir/trial/39001 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Participants will allocate in each group by: Block Sampling, individual, Stratified Randomization, tools used: Computer Software, Blinding description: in this study investigator and participants are blind from groups and how they are randomized. 2 Type 2 Diabetes. Intervention 1: Intervention Group 1: Zinc Supplement (contains 25mg zinc gluconate, Produced in Dine pharmacy Company, 1 time per day for 2 months, consume with water) and Selenium Supplement (Contains 100 mcg sodium selenite, produced in School of pharmacy's MUMS, 1 time per day for 2 months, consume with water). Intervention 2: Control group: Receive 1 Zinc Placebo tab (Produced in Dine Pharmacy company) and 1 Selenium placebo tab (Produced in school of Pharmacy at Mashhad University of Medical Sciences). Intervention 3: Intervention group 2: Zinc Supplement (contains 25mg zinc gluconate, Produced in Dine pharmacy Company, 1 time per day for 2 months, consume with water) and Selenium Placebo ( Produced in School of pharmacy's MUMS, 1 time per day for 2 months, consume with water). Intervention 4: Intervention group 3: Intervention Group 1: Zinc Placebo ( Produced in Dine pharmacy Company, 1 time per day for 2 months, consume with water) and Selenium Supplement (Contains 100 mcg sodium selenite, produced in School of pharmacy's MUMS, 1 time per day for 2 months, consume with water). Yes - There is a plan to make this available What will be shared: Primary outcomes will be share. When: Starting 6 month after publication To whom: Researchers Conditions: For Metanalysis Where to obtain: Making contact with Dr. Mariam Khosravi How to obtain: Making contact with Dr. Mariam Khosravi and asking for the data, if she approved, request will be send to university president, if they approved the data will send for applicant. Comments:
public Hamed Khedmatgozar
Nutrition Department, medicine School, Mashhad University of Medical Sciences, Univesity campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2367 khedmatgozarh961@mums.ac.ir Mashhad University of Medical Sciences scientific Mariam Khosravi
Department of Nutrotion, medicine school, Mashhad University of Medical Sciences, University campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2367 khosravim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Type 2 Diabetes Melitus 7< HA1c < 9 18.5 < BMI < 30 18 < Age < 65 18 years 65 years Both Zinc and Selenium consumption in last 3 month Diabetes complications autoimmune disorders cancer participating in any other studies pregnancy Lactating Smoking E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Treatment - Drugs Treatment - Drugs Intervention Group 1: Zinc Supplement (contains 25mg zinc gluconate, Produced in Dine pharmacy Company, 1 time per day for 2 months, consume with water) and Selenium Supplement (Contains 100 mcg sodium selenite, produced in School of pharmacy's MUMS, 1 time per day for 2 months, consume with water). Control group: Receive 1 Zinc Placebo tab (Produced in Dine Pharmacy company) and 1 Selenium placebo tab (Produced in school of Pharmacy at Mashhad University of Medical Sciences) Intervention group 2: Zinc Supplement (contains 25mg zinc gluconate, Produced in Dine pharmacy Company, 1 time per day for 2 months, consume with water) and Selenium Placebo ( Produced in School of pharmacy's MUMS, 1 time per day for 2 months, consume with water). Intervention group 3: Intervention Group 1: Zinc Placebo ( Produced in Dine pharmacy Company, 1 time per day for 2 months, consume with water) and Selenium Supplement (Contains 100 mcg sodium selenite, produced in School of pharmacy's MUMS, 1 time per day for 2 months, consume with water). Hemoglobin A1c. Timepoint: Before and after study. Method of measurement: Laboratory test. FBS. Timepoint: Before and after of intervention. Method of measurement: Laboratory test. Insulin. Timepoint: Before and after intervention. Method of measurement: Laboratory test. Interleukin 1 beta. Timepoint: Before and after intervention. Method of measurement: Laboratory test. Superoxide Dismutase. Timepoint: Before and after intervention. Method of measurement: Laboratory test. Glutathione peroxidase. Timepoint: Before and after intervention. Method of measurement: Laboratory test. Mashhad University of Medical Sciences Approved 2019-03-13 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, University campus, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)