Effect of Treating Vitamin D Deficiency on Postoperative Atrial Fibrillation after Coronary Artery Bypass Surgery: A Double Blinded Randomized Controlled Trial

1) assessing vitamin d level before surgery in controlled and intervention group 2) assessing occurrence of atrial fibrillation after the surgery 3) assessing number of attacks after the surgery 4) assessing requiring any drug for atrial fibrillation after the surgery

parallel randomized placebo-controlled double blinded clinical trial with 400 participants with vitamin d deficiency

by taking a blood sample we will evaluate the inclusion and exclusion criteria, then an echocardiography will assess the valvular problems and the left ventricular function of the heart. the patients will randomly allocated into two groups in which placebo and active drug will use. the holik's protocol conducted for the 8 weeks before the surgery and then right before the surgery another blood sample and an echocardiography will show us the differences in these 8 weeks after that the cabg perform by one surgeon and the same operation team. after that the patient go to the ICU as a routine procedure and during that they are under full 24hours monitoring and if the specific nurse sees any changes in lead 2 of the monitor, she will take a 12 lead electrocardiography which will interpreted for atrial fibrillation. the atrial fibrillation is defined as irregular heart rhythm with tachycardia in which p waves do not have equal distance fro each other.

inclusion criteria: 1) hypovitaminisis d 2) tent to participate in this project 3) aged 40-70 4) have cabg surgery indications like occlusion of three vessels not including in this study criteria: 1) having atrial fibrillation before or consuming any drug for that 2) normal level vitamin d 3) not to tend in this project 4) have any valvular problem 5) hyperparathyroidism 6) thyroid dysfunction 7) chronic obstructive pulmonary disease 8) liver failure 9) renal failure 10) having any cancer exclusion criteria: 1) vitamin d toxicity 2) hypercalcemia 3) decreased renal function during the project 4) morbid obesity

In this study we will treat vitamin D deficiency under Holick’s protocol using 50,000 IU of Vitamin D3 (cholecalciferol) every week for 8 weeks to achieve the sufficient level (30<25(OH) Vitamin D<80) and then 50,000 IU every month (4weeks) till the end of the study. Vitamin D3 (cholecalciferol) will be bought from pharmaceutical company.

atrial fibrillation occurrence after CABG, number of attacks, whether they need drug for atrial fibrillation, ejection fraction of the heart and left ventricular end diastolic volume according to pre and post op echocardiography

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.

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.

we just publish our protocol and analyzed result for publication

2020

mehran shahzamani

from published article

2019

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