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IRCT201506185623N45 IRCT 2015-06-22 Kashan University of Medical Sciences Effect of supplementation in treatment of Coronary Heart Disease Effects of calcium, vitamins D and K co-supplementation on insulin resistance, inflammatory factors and biomarkers of oxidative stress in Coronary Heart Disease 2015-06-02 anticipated 66 Complete https://irct.ir/trial/6075 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D, K and calcium supplements (n = 33) or placebo (n = 33). Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the cardiology clinic affiliated to Kashan University of Medical Sciences (KUMS), Kashan, Iran, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 3 Coronary Heart Disease. Intervention 1: Intervention group: Combined 200 IU vitamin D, 90 µg vitamin K2 and 500 mg calcium supplements daily twice for 12 weeks orally. Intervention 2: Control group: Placebo tablet, daily, twice for 12 weeks orally. 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 Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5562 0608 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Bolvare Ghotbe Ravandi, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Overweight patients (BMI≥25) with T2DM Aged 40-85 years old with CHD 40 years 85 years Both Consuming vitamin D, K and calcium supplements within the last 3 months Having an acute myocardial infarction within the past 3 months Having a cardiac surgery within the past 3 months A major renal or liver failure I25.9 Chronic ischaemic heart disease, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Combined 200 IU vitamin D, 90 µg vitamin K2 and 500 mg calcium supplements daily twice for 12 weeks orally. Control group: Placebo tablet, daily, twice for 12 weeks orally. Carotid intima media thickness. Timepoint: Baseline and End-of-trial. Method of measurement: Sonography. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Kashan University of Medical Sciences Approved 2015-06-01 Kashan University of Medical Sciences Bolvare Ghotbe Ravandi, Kashan Kashan Isfehan Iran (Islamic Republic of)