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IRCT201404271485N12 IRCT 2014-05-18 Isfahan University of medical sciences Effect of magnesium supplementation on improvement of patients with diabetic nephropathy Effect of magnesium supplementation on kidney function, insulin resistance and metabolic profile in patients with diabetic nephropathy 2014-04-22 anticipated 80 Complete https://irct.ir/trial/771 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After stratification for age, sex, type and dose of medication and BMI, subjects were randomly assigned to receive either magnesium supplements or placebo, Blinding description: Placebo was similar in appearance (color, shape, size and packaging) with supplements. Patients were indicated by numbers for principle investigator. Supplement or placebo were handed over the participants by two other health provider not related to the trial. 2 Diabetes. Intervention 1: Magnesium supplement, each tablet contains 250 mg magnesium oxide, 1 time a day for 12 weeks. Intervention 2: Placebo, similar color, odor and appearance to magnesium supplement, 1 time a day for 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no data sharing agreement from the related organization.
public Ahmad Esmaeilzade
College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81745-151 +98 31 1792 2776 esmaillzadeh@hlth.mui.ac.ir Isfahan University of Medical Sciences scientific Ahmad Esmaeilzade
College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
Isfahan Iran (Islamic Republic of) 81745-151 +98 31 1792 2776 esmaillzadeh@hlth.mui.ac.ir Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic Iran (Islamic Republic of) More than 18 years old Diabetic nephropathy Blood glucose more than 126 milligram per decilite Proteinuria between 30 to 300 milligram per deciliter (micro-albuminuria) Glomerular Filtration Rate more than 90 milliliter per minute Not having hypothyroidism and hyperthyroidism; Not having any urine duct infection; Not having any feverish infection; Not using cigarette or other drugs; Not having liver disease; Not having cancer; Not having any inflammatory disease Not losing weight more than 4 kilogram during last 3 months Not using any magnesium-rich supplement 18 years 80 years Both Changing medicine doses failure to adherence (using less than 75 percent of medicines) N08.3 Diabetic nephropathy Treatment - Drugs Treatment - Drugs Magnesium supplement, each tablet contains 250 mg magnesium oxide, 1 time a day for 12 weeks Placebo, similar color, odor and appearance to magnesium supplement, 1 time a day for 12 weeks Albumin to creatinine ratio (UACR). Timepoint: Baseline, week 12. Method of measurement: Commercial kit. Blood Urine Nitrogen. Timepoint: Baseline, week 12. Method of measurement: Commercial kits. Glomerular Filtration Rate. Timepoint: Baseline, week 12. Method of measurement: commercial kits. Proteinuria. Timepoint: Baseline, week 12. Method of measurement: Methyl benzatonium chloride method. Fasting Blood Sugar. Timepoint: Baseline, week 12. Method of measurement: Commercial kits. Hemoglubin A1c. Timepoint: Baseline, week 12. Method of measurement: High-Performance Liquid Chromatography. Serum insulin. Timepoint: Baseline, week 12. Method of measurement: Enzyme-Linked Immunosorbent Assay. High Density Lipoprotein. Timepoint: Baseline, week 12. Method of measurement: Commercial kits. Low Density Lipoprotein. Timepoint: Baseline, week 12. Method of measurement: Commercial kits. Very Low Density Lipoprotein. Timepoint: Baseline, week 12. Method of measurement: Commercial kits. Triglyceride. Timepoint: Baseline, week 12. Method of measurement: Commercial kits. Total Cholesterol. Timepoint: Baseline, week 12. Method of measurement: Commercial kits. C-Reactive Protein. Timepoint: Baseline, week 12. Method of measurement: Enzyme-Linked Immunosorbent Assay. Creatinine. Timepoint: Baseline, week 12. Method of measurement: Commercial kits. Isfahan University of medical sciences Approved 2014-04-19 Ethical Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Ave, Isfahan Isfahan Isfehan Iran (Islamic Republic of)