association between vitamin D administration and pathological feature of cardiac cell in patients with low Vitamin D who are candidates for coronary artery bypass graft(CABG) surgery for the first time
Determinate the effect of Vitamin D supplement administration on pathological feature of cardiomyopathy in patients whom had Vitamin D insufficiency and refer to hospital for coronary artery bypass graft (CABG)
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This study was conducted in cardiac surgery ward in Shaheed Modarres Hospital.Patients were assign by a computerized software into two groups.After the intervention ,we will measure Apoptosis indicators including: Capase 2 , Caspase 3 ,Caspase 7, , Insulin GF , IL-10 in three sets of times.3 days before surgery and the day of surgery and one day after surgery. Caspase enzyme will be measured by immunohistochemistery (IHC) and other factors will be measured by ELISA. IHC will be done on right atrium auricle. In this study patients, laboratory technicians, pathologist and statistician were blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria :1.Patients whom having CABG for the first time 2.Patients only with coronary surgery and no valvular one 3.Patients that have surgery with cardiopulmonary pump 4.Patienst with Vitamin D level less than 30 ng/ml
Exclusion criteria :
1.Patients with Renal failure or creatinine level more than 1.5 mg/dl
2.Patients who have been Vitamin D taken
Intervention groups
controlled group: 33 patients that will receive placebo for 3 days and each day for 3 doses
intervention group is 33 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units
association between vitamin D administration and pathological feature of cardiac cell in patients with low Vitamin D who are candidates for coronary artery bypass graft(CABG) surgery for the first time
Public title
Can Vitamin D reduce heart damage in cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients that have CABG surgery for the first time
patients only with coronary surgery and no valvular surgery
patients that we use cardipulmonary pump during the surgery
patients with vitamin D level less than 30 ng/ml
Exclusion criteria:
Patients who have Renal failure
creatinine higher than 1.5 mg/dl
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization was simple and its unit was individuals.we used a computer software for randomization.For allocation concealment all of the ICU nurses that took care of patients, lab technicians who did the ELISA, pathologist who did the IHC and all the patients were not aware of the randomization process.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each patient will assign to a specific code and they will receive a same looking drug
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ISRCTN registry
Secondary trial Id
35981
Registration date
2018-11-17, 1397/08/26
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Shahid Beheshti medical university