Goal of this study is the evaluation of effect of vitamin D on the incidence of atrial fibrilation after CABG.
Design of the study is randomized,triple blind,control with placebo
Inclusion criteria: Vit D insufficienct (<20ng/ml) patients who undergo CABG
Exclusion criteria: concurrent valvular surgery and CABG; History of supraventricular arrhythmias; Use of anti arrhythmic drugs except beta blockers, calcium channel blochers or digital compounds; Use of anti seizure drugs; Hypercalcemia; History of allergy to cholecalciferol; Emergency CABG; Chronic liver dis.; Chronic kidney dis.; Pace maker; Use of Mg
Sample size 80 patients in drug group and 80 patients in placebo group
Intervention: 600000IU vit D3 in injected to the drug group and placebo is injected to the placebo group
Time of intervention 3-5 days before surgery
Primary end point is atrial fibrilation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511298698N16
Registration date:2016-05-21, 1395/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmacy faculty
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of vitamin D on the prevention of postoperative atrial fibrillation following coronary artery bypass grafting (CABG) surgery
Public title
The effect of vitamin D on AF after CABG surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Vit D insufficienct (<20ng/ml) patients who undergo CABG surgery
Exclusion criteria: concurrent valvular surgery and CABG; History of supraventricular arrhythmias; Use of anti arrhythmic drugs except beta blockers,calcium channel blochers or digital compounds; Use of anti seizure drugs; Hypercalcemia; History of allergy to cholecalciferol; Emergency CABG; Chronic liver dis; Chronic kidney dis.; Pace maker; Use of Mg
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tehran University of Medical Sciences
Street address
4th floor, NO.23, 16 Azar st. , Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2016-01-11, 1394/10/21
Ethics committee reference number
IR.TUMS.REC.1394.1617
Health conditions studied
1
Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Atrial fibrilation
Timepoint
After CABG for 5 days
Method of measurement
ECG
2
Description
CRP
Timepoint
Daily for 5days
Method of measurement
laboratory
Secondary outcomes
1
Description
ICU stay
Timepoint
Time of transfer to ward
Method of measurement
days
Intervention groups
1
Description
600000 IU vit D3 is injected(3-5 days before surgery)
Category
Treatment - Drugs
2
Description
Placebo is injected before surgery(3-5 days before surgery)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Maryam Daei
Street address
Tehran Heart Center.next to Shariati hospital, north Karegar street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor,Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Vice chancellor, 6th floor, university central organisation, next to Ghods Street, Keshavarz boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor,Tehran University of Medical Sciences