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IRCT20190206042646N1 IRCT 2019-04-03 Ghoum University of Medical Sciences Study the effect of oral supplements “zinc and magnesium” on diabetes Study the effect of oral supplements “zinc and magnesium” on the control of Hemoglobin A1c in type II diabetic patients referred to Qom Shahid Beheshti hospital 2017-2018 2019-04-04 anticipated 80 Complete https://irct.ir/trial/37396 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: Random allocation method is based on blocking. Four blocks are used. The list of 24 blocks is written and randomly a number is selected and the sampling is continued based on it. ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, BACD, BADC, BCAD, BCDA, BDAC, BDCA, CABD, CADB, CBAD, CBDA, CDAB, CDBA, DABC, DACB, DBCA, DBAC, DCAB, DCBA, Blinding description: After dividing people into four different groups, patients are referred to the clerk and they train their medication and the correct way of taking them. Medications are pre-prepared and packaged out and packed in new ones as they are inserted on new packets of English letters, and the person who does not have direct intervention knows their meaning. Drug and placebo formulations of the same color The color and appearance of zinc, magnesium, and placebo tablets are identical. Patients refer to the doctor after the assignment of the code in the group and the physician is unaware of their allocation to the different groups and only the secretary delivers the package of the patient package to the patient. 3 Diabetes mellitus type2. Intervention 1: Intervention group1: People with type 2 diabetes, who in addition to medication, receive oral zinc in the amount of 220 mg zinc sulfate, three days a week for six months. Intervention 2: Intervention group 2: People with type 2 diabetes receive magnesium oxide 250 mg three days a week for six months in addition to medication. Intervention 3: Intervention group 3: People with type 2 diabetes, who in addition to medication, receive magnesium oxide 250 mg three days a week and oral zinc as zinc sulfate at 220 mg three days a week for six months. Intervention 4: Control group: The control group, which includes people with type 2 diabetes, who receive placebo only for six months in addition to medication. Yes - There is a plan to make this available What will be shared: All data can be shared after unidentifiable patients. When: Start the access period one year after the publishing results To whom: Researchers working in academic centers and pharmaceutical companies Conditions: The use of data obtained for the purpose of directing and completing research projects is permissible. Where to obtain: To receive the data, send your request to Narges Kalhor at narges.kalhor1997@gmail.com. How to obtain: The request will be reviewed by the clinical trial responsible and the data will be sent to him after verifying the accuracy of the information received from the applicant. Comments:
public Reyhaneh Tabaraii
Shahid Beheshti Hospital, Shahid Beheshti Blvd., Qom
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 Rt1356@yahoo.com Ghoum University of Medical Sciences scientific Reyhaneh Tabaraii
Shahid Beheshti Hospital, Shahid Beheshti Blvd., Qom
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 Rt1356@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Individual consent Diabetic Type 2 Proven by Metabolic Indicators (FBS and 2HBP) At least 3 years of diabetes history aged over 20 20 years 60 years Both - Age over 60 Individual with a history of myocardial infarction Individual with hypermagnesemia Individual with hyperzincemia Patient with diabetic nephropathy Insulin Consumers E11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group1: People with type 2 diabetes, who in addition to medication, receive oral zinc in the amount of 220 mg zinc sulfate, three days a week for six months. Intervention group 2: People with type 2 diabetes receive magnesium oxide 250 mg three days a week for six months in addition to medication. Intervention group 3: People with type 2 diabetes, who in addition to medication, receive magnesium oxide 250 mg three days a week and oral zinc as zinc sulfate at 220 mg three days a week for six months. Control group: The control group, which includes people with type 2 diabetes, who receive placebo only for six months in addition to medication. Percentage of hemoglobin A1c in people with type 2 diabetes. Timepoint: Measurement of hemoglobin A1c at baseline, 3 and 6 months after the start of the intervention. Method of measurement: Biochemical analysis by reference laboratory. Peripheral neuropathy in patients with type 2 diabetes. Timepoint: Measurement of hemoglobin A1c at baseline, 3 and 6 months after the start of the intervention. Method of measurement: Michigan Neuropathy Survey Instrument(MNSI). Ghoum University of Medical Sciences Approved 2019-01-01 Ethics committee of Qom University of Medical Science Deputies Education & Research, No.83, Ave. 1/1, safashahr St., Qom Qom Ghoum Iran (Islamic Republic of)