Protocol summary
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Study aim
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Investigate the effect vitamin D supplementation on atrial fibrillation incidence
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Design
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Clinical trial with control group, with parallel groups, without blinding, randomized, Phase 3 on 160 patients. Randomization is performed by statistician and random allocation of one arrangement to one block
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Settings and conduct
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This trial is held in Tehran heart center. Included patients are randomly divided into two groups. One group receives 600000IU cholecalciferol pearl. Patients are monitored for the occurrence of atrial fibrillation after surgery for 5 days
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients older than 18 years who are to undergo CABG surgery with 25 hydroxy vitamin D levels less than 30ng/ml and a stable hemodynamic.
Exclusion criteria: Concurrent valvular surgery, redo surgery, emergency CABG, history of supraventricular arrhythmia, use of anti arrhythmic drugs except for beta blockers, digoxin and calcium channel antagonists, current use of any vitamin D or magnesium supplement, drugs affecting vitamin D metabolism, hypercalcemia, history of cholecalciferol hypersensitivity, chronic kidney disease, chronic liver disease
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Intervention groups
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Patients are divided into two groups. One group receives 600000IU cholecalciferol pearl in addition to routine cares of CABG surgery candidates and the other group just receives the routine care of CABG patients.
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Main outcome variables
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Occurrence of POAF during the first 5 days after surgery
General information
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Reason for update
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To Complete study information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201511298698N16
Registration date:
2016-05-21, 1395/03/01
Registration timing:
registered_while_recruiting
Last update:
2020-07-23, 1399/05/02
Update count:
1
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Registration date
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2016-05-21, 1395/03/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Pharmacy faculty
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Expected recruitment start date
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2016-04-08, 1395/01/20
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Expected recruitment end date
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2017-02-28, 1395/12/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of vitamin D on the prevention of postoperative atrial fibrillation following coronary artery bypass grafting (CABG) surgery
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Public title
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The effect of vitamin D on AF after CABG surgery
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patient is older than 18 years old
Patient is vitamin D deficient (<30ng/ml)
Patient is to undergo CABG surgery
Patient has a stable hemodynamic
Exclusion criteria:
Concurrent valvular surgery
History of supraventricular arrhythmias
Use of anti arrhythmic drugs except beta blockers,calcium channel blochers or digital compounds
Use of drugs affecting vitamin D metabolism
Hypercalcemia
History of allergy to cholecalciferol
Emergency CABG surgery
Chronic liver disease
Chronic kidney disease
Current use of vitamin D supplement
Redo CABG surgery
Current use of Mg supplement
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
160
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is performed with Permuted block randomization method by statistician. ُStatistician determines the possible arrangements of blocks of size of 4 for patients. Randomly one arrangement is chosen for each block.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-01-11, 1394/10/21
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Ethics committee reference number
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IR.TUMS.REC.1394.1617
Health conditions studied
1
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Description of health condition studied
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Atrial fibrillation
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ICD-10 code
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I48
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ICD-10 code description
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Atrial fibrillation and flutter
Primary outcomes
1
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Description
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Atrial fibrilation
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Timepoint
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After CABG for 5 days
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Method of measurement
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ECG
2
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Description
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CRP
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Timepoint
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Daily for 5days
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Method of measurement
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laboratory
Secondary outcomes
1
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Description
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ICU stay
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Timepoint
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Time of transfer to ward
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Method of measurement
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days
2
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Description
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Hospital stay
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Timepoint
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Length of hospital stay
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Method of measurement
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days
Intervention groups
1
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Description
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600000 IU oral vit D3 (3-5 days before surgery)
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Category
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Treatment - Drugs
2
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Description
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The patient did not receive any intervention
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The information about primary outcome can be shared
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When the data will become available and for how long
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After publication
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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The user should send his/her resuest for Dr. Talasaz
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From where data/document is obtainable
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Dr Azita Haj Hossein Talasaz
Tehran Heart Center- North Karegar- Tehran
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What processes are involved for a request to access data/document
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The applicant posts his/her requested information for Dr. Talasaz. Dr Talasaz sends her reply after investigating the request and after a maximum of 3 months.
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Comments
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