the comparison of Effect of calcitriol and cholecalciferol on cardiac biomarkers in patients undergoing elective percutaneous coronary intervention, a randomized controlled study
Evaluation of the effect of cholecalciferol or calcitriol addition to the pre operation standard regimen in the decrease of cardiac injury following elective percutaneous coronary intervention
Design
Phase 3 randomized, blinded, parallel design clinical trial on 180 patients. Randomization will be performed by rand function in Excell software.
Settings and conduct
This clinical trial will be conducted in Alzahra and Shahid Faghihi medical centers affiliated to shiraz university of medical sciences on patients receiving elective percutaneous coronary intervention. patients will assign to receive cholecalciferol or calcitriol orally prior to the intervention.
Participants/Inclusion and exclusion criteria
patients with the diagnosis of ischemic heart disease with the age of 18 to 80 with vitamin D level of less than 30 ng/mL years who are candidate to receive percutaneous coronary intervention will be recruited. patients with the elevated cardiac biomarker or history of myocardial infarction or who received coronary artery bypass graft in the last 3 months, history of receiving cholecalciferol or calcitriol or a containing multi vitamin in the last month or received unsuccessful percutaneous coronary intervention will be excluded from the study,
Intervention groups
Included patients will assign in intervention group 1, intervention group 2 or control group. patients in intervention group 1 will receive cholecalciferol by the dose of 300000, in intervention group 2 will receive calcitriol by the dose of 1 micro gram in intervention group. Patients in control group will receive no intervention.
Main outcome variables
Elevation of Troponin I and High sensitivity C-reactive protein and Creatine kinase-MB
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150518022306N3
Registration date:2020-08-20, 1399/05/30
Registration timing:registered_while_recruiting
Last update:2020-08-20, 1399/05/30
Update count:0
Registration date
2020-08-20, 1399/05/30
Registrant information
Name
Sara Asadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4128
Email address
asadi_s@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the comparison of Effect of calcitriol and cholecalciferol on cardiac biomarkers in patients undergoing elective percutaneous coronary intervention, a randomized controlled study
Public title
Calcitriol and cholecalciferol effect on cardiac biomarkers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients diagnosed with Coronary artery disease who hospitalized due to performing elective percutaneous Coronary Intervention (angioplasty with stent)
Vitamin D level of less than 30 ng/mL
Exclusion criteria:
patients with myocardial infarction or history of coronary artery bypass graft in last 3 months
patients with history of vitamin D supplementation in the last 1 month prior to hospitalization
patients with history of unsuccessful PCI
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will assign to two intervention groups and a control group via computer generated simple randomization method. The random allocation sequence will computer generate and consist of series of group number (either 1 = A or 2 = B) for each consecutive patient. Computer generated randomization will be performed by Excel software via #Rand function.
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients were assigned to two intervention groups or a control group, randomly by principle investigator. ِData analyzer will be blinded to the randomization and group assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Fars Province, Shiraz, Zand st,
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Approval date
2019-05-08, 1398/02/18
Ethics committee reference number
IR.SUMS.REC.1398.513
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
comparison any change in level of troponin-I
Timepoint
at baseline and 24 hours after Percutaneous Coronary Intervention
Method of measurement
serum level
2
Description
comparison any change in level of High Sensitivity C-Reactive Protein (hsCRP)
Timepoint
At baseline and 24 hours after Percutaneous Coronary Intervention
Method of measurement
serum level
3
Description
comparison any change in level of Creatine kinase-MB
Timepoint
At baseline and 24 hours after Percutaneous Coronary Intervention
Method of measurement
serum level
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: recieving 300000 internatinal unit cholecalciferol orally 12 hours before Percutaneous Coronary Intervention (Daana Pharma)