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IRCT20230506058103N1 IRCT 2023-05-20 Shahid Beheshti University of Medical Sciences effect of vitamin D in incidence of atrial fibrillation Effect of Preoperative Vitamin D Supplementation on Atrial Fibrillation Incidence After Coronary Artery Bypass Graft 2023-07-23 anticipated 246 Complete https://irct.ir/trial/69986 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization will be done using a block method (4 patients in each block). At first, the patients will be divided into groups of four according to the time of entry into the study, and the list of groups will be randomly divided into two lists A and B using random.org. The intervention receiving group will be determined based on a coin toss. Also, the stages of the study are performed in a double-blind manner in terms of the patients, the interventionist and the analyst. Randomization and enrollment of patients into two groups will be done by a third party (secretary of cardiac surgery department) and the patients, the main researchers and the data analyst will not be aware of the randomization result, Blinding description: Patients, outcome assessors and clinical caregivers will not be informed of the randomization result. Randomization and enrollment of patients into two groups will be done by a third party (secretary of cardiac surgery department) and the patients, the main researchers and the data analyst will not be aware of the randomization result. The data presented to the data analyst will be anonymous. 3 atrial fibrillation. Intervention 1: Intervention group: Patients receiving vitamin D: The intervention group, starting 3 days before the surgery, will receive a daily dose of vitamin D supplements in the form of 150 thousand units (3 doses of 50 thousand units in the morning, noon and night) and a total of 450 thousand units. Intervention 2: Control group: patients receiving placebo: Patients in the placebo group will receive a placebo similar to the original drug, similar to the intervention group (starting three days before surgery and three times a day). No - There is not a plan to make this available Justification or reason for not sharing IPD is The data will remain confidential with the researcher; Other researchers will receive de-identified personal data of the participants by sending an email to the principal investigator if they provide a valid reason for needing the data of this study.
public Arezoo Hayatimoghaddam
No.1, 13th golestan ave., golestan blvd., east marzdaran
Tehran Iran (Islamic Republic of) 1463775739 +98 21 4427 1889 Arezoo_Hyti_27@yahoo.com Shahid Beheshti University of Medical Sciences scientific Arezoo hayatimoghaddam
No.1, 13th golestan Ave., golestan Blvd., east marzdaran
Tehran Iran (Islamic Republic of) 1463775739 +98 21 4427 1889 Arezoo_Hyti_27@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) presence of Vitamin D deficiency Being a candidate for coronary artery bypass graft surgery Consent to participate in the study no limit no limit Both history of atrial fibrillation before surgery receiving antiarrhythmic drugs (except beta blockers) history of chronic obstructive pulmonary disease Pacemaker brokerage experience history of renal failure hypercalcemia history of kidney stone history of emergency surgeries History of multiple surgeries history of hyperthyroidism history of sarcoidosis History of malabsorption syndrome History of bleeding and tamponade History of off pump coronary artery bypass grafting redo surgery History of receiving vitamin D and calcium supplements I48 Atrial fibrillation and flutter Treatment - Drugs Placebo Intervention group: Patients receiving vitamin D: The intervention group, starting 3 days before the surgery, will receive a daily dose of vitamin D supplements in the form of 150 thousand units (3 doses of 50 thousand units in the morning, noon and night) and a total of 450 thousand units. Control group: patients receiving placebo: Patients in the placebo group will receive a placebo similar to the original drug, similar to the intervention group (starting three days before surgery and three times a day). Percentage of people with atrial fibrillation. Timepoint: incidence of atrial fibrillation During hospitalization after Coronary artery bypass grafting. Method of measurement: Monitoring the patient's electrocardiogram. Shahid Beheshti University of Medical Sciences Approved 2022-10-23 Medical School ethics committee of shahid beheshti university of medical sciences daneshjoo Blvd., velenjak, tehran Tehran Tehran Iran (Islamic Republic of)