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IRCT20130211012438N31 IRCT 2019-05-11 Kashan University of Medical Sciences The effect of magnesium and zinc co-supplementation in patients with coronary heart disease and type 2 diabetes mellitus The effect of magnesium and zinc co-supplementation on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus 2019-01-05 anticipated 60 Complete https://irct.ir/trial/36480 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization is that the patients are placed on separate classes according to two criteria: BMI (BMI <25 BMI≥25) and age (<65 and 65≤), and then randomly in one of two groups receiving magnesium and zinc supplements and the placebo group (containing starch) are included. The study is done using the Stat Trek software, Blinding description: Supplements and placebo after coding by the researcher are placed under supervision of clinical caregiver and then clinical caregiver provided them to the participants. Both clinical caregiver and participants are kept blind. 3 coronary heart disease and type 2 diabetes mellitus. Intervention 1: Intervention group: a capsule containing150 mg zinc sulfate and 250 mg magnesium oxide once a day for 3 months. Intervention 2: Control group: 1000 mg Placebo capsule containing corn starch Once a day for 3 months. 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 Undecided - It is not yet known if there will be a plan to make this available
public zahra Hamedifard
Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
Kashan Iran (Islamic Republic of) 88715973474 +98 31 5554 0021 z.hamedifard.sb@gmail.com Kashan University of Medical Sciences scientific mohsen taghizadeh
Kashan University of Medical Sciences, Kashan, Iran
Kashan Iran (Islamic Republic of) 8719675537 +98 31 5533 3213 Taghizadeh_m@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) patients with coronary disease on angiography ;patients with diabetes with American Diabetes Association; age 40 to 95 years;No smoking 40 years 95 years Both thyroid disease;No change in levels of LDL patients six weeks after the intervention;Infection; Consumption of any type of supplement (vitamin, mineral, etc.) by the patient in the last 3 months; Acute myocardial infarction in the last 3 months; Cardiac surgery in the last 3 months; Significant kidney failure; Significant liver failure; Unwillingness to cooperate; Antibiotic use during study I25.9 Chronic ischemic heart disease, unspecified Treatment - Drugs Placebo Intervention group: a capsule containing150 mg zinc sulfate and 250 mg magnesium oxide once a day for 3 months Control group: 1000 mg Placebo capsule containing corn starch Once a day for 3 months HOMA-Index. Timepoint: Baseline and End-of-trial. Method of measurement: Formula calculation. Fasting plasma glucose. Timepoint: Fasting plasma glucose. Method of measurement: Enzymatic. Insulin. Timepoint: Baseline and End-of-tria. Method of measurement: Elisa. QUICKI. Timepoint: Baseline and End-of-tria. Method of measurement: Formula calculation. Beck Depression Inventory. Timepoint: Baseline and End-of-tria. Method of measurement: Questionnaire. Nitric oxide (NO). Timepoint: Baseline and End-of-tria. Method of measurement: Spectrophotometry. High sensitivity C-reactive protein (hs-CRP). Timepoint: Baseline and End-of-tria. Method of measurement: Elisa. Total Antioxidant Capacity (TAC). Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Total glutathione. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Malondialdehyde(MDA). Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry. Serum Total cholestrol. Timepoint: Baseline and End-of-trial. Method of measurement: Laboratory clinical kit. Serum LDL-C. Timepoint: Baseline and End-of-trial. Method of measurement: Laboratory clinical kit. HDL-C سرم. Timepoint: Baseline and End-of-trial. Method of measurement: Laboratory clinical kit. Serum Triglyceride. Timepoint: Baseline and End-of-trial. Method of measurement: Laboratory clinical kit. Beck Anxiety Inventory. Timepoint: Baseline and End-of-trial. Method of measurement: Questionnaire. Kashan University of Medical Sciences Approved 2018-12-10 Ethics Committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd. Kashan Isfehan Iran (Islamic Republic of)