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IRCT20170620034666N1 IRCT 2018-03-05 isfahan university of medical sciences Treating Vitamin D Deficiency on Post CABG Atrial Fibrillation VIDAF Effect of Treating Vitamin D Deficiency on Postoperative Atrial Fibrillation after Coronary Artery Bypass Surgery: A Double Blinded Randomized Controlled Trial 2018-04-04 anticipated 400 Complete https://irct.ir/trial/29672 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: consecutive sampling is applicable in clinic in which we want to choose the participant, the surgeon evaluates the inclusion and exclusion criteria then by using a Random bottom of calculator, the last number at right will be chosen, if it is even the patient go to group A, and if it is odd the patient go to the group B, then the next patient will be the reverse and this process repeated for each 2 patients and this will allocated patients in 2 group of equal number of patients, Blinding description: This study will conducted under double blinded manner in which both patients and researchers will be blinded about the placebo and drug groups until completing the study. The placebo will be identical as the drug and the pharmaceutical company will provide this for us. 2 Condition 1: . Condition 2: vitamin d deficiency. Condition 3: atrial fibrillation after the surgery. Intervention 1: Intervention group: receiving vitamin d active drug. Intervention 2: Control group: receiving placebo. Yes - There is a plan to make this available What will be shared: we just publish our protocol and analyzed result for publication When: 2020 To whom: mehran shahzamani Conditions: from published article Where to obtain: 2019 How to obtain: email Comments:
public Mehran Shahzamani
Isfahan-hezar jerib st
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3670 1227 m.shahzamani@med.mui.ac.ir Isfahan University of Medical Sciences scientific Mehran Shahzamani
Isfahan-hezar jerib st
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3670 1227 m.shahzamani@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) b) Hypovitaminosis D (serum 25(OH) Vitamin D< 20 ng/ml) c) Written and informed consent to participate in this project CABG indications like trivessel occlusion no emergency intervention needed 30 years 70 years Both e) Hyperparathyroidism (PTH>upper normal limit according to lab reference range) f) Liver failure (any positive past medical history or AST and/or ALT 2 times more than normal upper limit) g) Renal Failure (any positive past medical history or Glomerular filtration rate <60 calculated with MDRD eGFR formula of Qx medical application ) h) Any prior history of diagnosed cancer, rheumatologic and immunologic disorders b) BMI>30 kg/m2 vitamin d toxicity hypercalcemia E55.9 I48 Vitamin D deficiency, unspecified Atrial fibrillation and flutter Treatment - Drugs Treatment - Drugs Intervention group: receiving vitamin d active drug Control group: receiving placebo Occurrence of atrial fibrillation after the surgery. Timepoint: till 7 days after the surgery 24 hours in ICU. Method of measurement: electrocardiography. Number of atrial fibrillation. Timepoint: till 7 days after the surgery 24 hours in ICU. Method of measurement: electrocardiography. Left ventricular function. Timepoint: before starting taking drugs, before surgery, before discharging from hospital. Method of measurement: echocardiography. Left ventricular function after 1 year. Timepoint: before starting taking drugs, before surgery, before discharge and 1 year after the surgery. Method of measurement: echocardiography. isfahan university of medical sciences Approved 2017-12-18 Isfahan University of Medical Sciences; Medical Ethics Board Committee hezar jarib blvd. ISFAHAN Isfehan Iran (Islamic Republic of)