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IRCT20221018056231N1 IRCT 2022-12-18 Esfahan University of Medical Sciences The effect of oral magnesium on glycemic and metabolic control in patients with type 1 diabetes The effectiveness of oral magnesium administration on blood sugar, glycosylated hemoglobin, and lipid profile parameters of patients with type 1 diabetes 2022-12-22 anticipated 120 Complete https://irct.ir/trial/66377 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, 60 eligible to enter study patients with type 1 diabetes, who are overweight or obese, are selected non-randomly. Then the letter A is written on 30 leaves and the letter B is written on 30 leaves and each is placed in an envelope. Then each patient is asked to choose one envelope from among the envelopes. Then,60 eligible to enter study patients with type 1 diabetes, who are not overweight or obese are selected non-randomly. Then the letter C is written on 30 leaves and the letter D is written on 30 leaves and each is placed in an envelope. Then each patient is asked to choose one envelope from among the envelopes. In this way, according to the envelope selected without the researcher's intervention, the patients will be randomly assigned to one of the intervention and control groups, Blinding description: In this study, magnesium sulfate and the placebo are prepared by the pharmacist in the same shape, size, and color and will be marked with A and B labels and provided to the researcher. He/She also prescribe them without knowing the type of each medicine. Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Type 1 diabetes. Intervention 1: Control group: For patients in this group, one gram sachets of placebo (Isfahan Faculty of Pharmacy) are prescribed for 6 months according to the standard instructions (according to the child's age). In this way, it will be prescribed three days a week for children 6-8 years old, five days a week for children 9-13 years old, and seven days a week (every day) for children 14 years old and above. Intervention 2: Intervention group: For patients in this group, 1 gr sachets of oral magnesium (Bonyan Salamat Kasra Company) containing 300 mg of pure magnesium are prescribed for 6 months according to the standard instructions (according to the child's age). In this way, it will be prescribed three days a week for children 6-8 years old, five days a week for children 9-13 years old, and seven days a week (every day) for children 14 years old and above. 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 further information
public Seyed Ebrahim Tabatabayipoor
Emamhosein Hospital, Emamkhomeini Blvd
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 5016 tabamohamad42@yahoo.com Esfahan University of Medical Sciences scientific Seyed Ebrahim Tabatabayipoor
Imamhosein Hospital, Imamkhomeini Blvd
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 5016 tabamohamad42@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Having type 1 diabetes Age range from 6 to 18 years 6 years 18 years Both History of sensitivity to magnesium compounds Suffering from chronic diseases Use of special medicine other than insulin Use of compounds containing calcium E10.9 Type 1 diabetes mellitus without complications Placebo Treatment - Drugs Control group: For patients in this group, one gram sachets of placebo (Isfahan Faculty of Pharmacy) are prescribed for 6 months according to the standard instructions (according to the child's age). In this way, it will be prescribed three days a week for children 6-8 years old, five days a week for children 9-13 years old, and seven days a week (every day) for children 14 years old and above. Intervention group: For patients in this group, 1 gr sachets of oral magnesium (Bonyan Salamat Kasra Company) containing 300 mg of pure magnesium are prescribed for 6 months according to the standard instructions (according to the child's age). In this way, it will be prescribed three days a week for children 6-8 years old, five days a week for children 9-13 years old, and seven days a week (every day) for children 14 years old and above. Blood sugar. Timepoint: Before intervention and 6 months after taking magnesium supplement. Method of measurement: Blood test. Glycosylated hemoglobin. Timepoint: Before intervention and 6 months after taking magnesium supplement. Method of measurement: Blood test. High-density lipoprotein cholesterol (HDL). Timepoint: Before intervention and 6 months after taking magnesium supplement. Method of measurement: Blood test. Low-density lipoprotein cholesterol (LDL). Timepoint: Before intervention and 6 months after taking magnesium supplement. Method of measurement: Blood test. Body mass index(BMI). Timepoint: Before intervention and 6 months after taking magnesium supplement. Method of measurement: Meters and Clinic scales. Esfahan University of Medical Sciences Approved 2022-10-24 Ethics committee of Isfahan University of Medical Sciences Ethics committee , Isfahan University of Medical Sciences, Hezarjarib Blvd, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)