Plain English Summary
Background and study aim
Heart diseases are among the most common cause of death worldwide. A large proportion of deaths are caused by heart attacks (myocardial infarction), where blood flow to the heart is reduced resulting in damage to the heart muscle. If the arteries supplying blood to the heart start to become blocked, coronary artery bypass graft (CABG) surgery to replace the blocked sections of artery can reduce angina (chest pain). However, CABG surgery has complications, including an increased risk of heart attack. Vitamin D deficiency is thought to be linked to poorer recovery from heart attack and CABG surgery. This study aims to investigate if vitamin D supplementation can reduce injury to the heart following CABG surgery.
Who can participate?
Adults with vitamin D deficiency undergoing CABG
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive vitamin D at 3 doses per day for 3 days before surgery. The second group will receive a dummy pill (placebo). Both groups will have standard CABG surgery.
What are the possible benefits and risks of participating?
Those in the vitamin D group might benefit from its effects. Vitamin D has few side effects, especially when taken for only a few days.
Where is the study run from?
Shahid Modarres Hospital (Iran)
When is the study starting and how long is it expected to run for?
September 2017 to January 2019
Who is funding the study?
Deputy of Research of Shahid Beheshti School of Medicine
Who is the main contact?
Dr Erfan Tasdighi
erfan.tasdighi@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Mr Erfan Tasdighi
ORCID ID
http://orcid.org/0000-0003-2146-7083
Contact details
Saadat Abad Boulevard
District 2
Tehran
1153733163
Iran
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1372
Study information
Scientific title
Association between vitamin D administration and cardiac cell pathology in patients undergoing CABG surgery
Acronym
Study hypothesis
Vitamin D adminestration in patients with vitamin D deficiency effect pathological feature of cardiac muscle cells
Ethics approval
Ethics committee of Shahid Beheshti Medical University, 04/11/2018, ref: IR.SBMU.RETECH.REC.1397.616
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Cardiomyopathy
Intervention
Participants undergoing coronary artery bypass graft (CABG) surgery are randomly allocated to group A (intervention), who receive 3 doses of vitamin D (50000 U) a day for 3 days before surgery or group B (control), who will receive placebo.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1. Caspase 2 enzyme level measured by IHC (immunohistochemistry) of right atrial auricle biopsy during and after surgery
2. Caspase 3 enzyme level measured by IHC of right atrial auricle biopsy during and after surgery
3. Caspase 7 enzyme level measured by IHC of right atrial auricle biopsy during and after surgery
4. Serum IL-10 level measured by ELISA before the intervention (3 days before surgery), just before the surgery, just after surgery and one day after surgery
5. Serum insulin-like growth factor level measured by standard laboratory test before the intervention (3 days before surgery), just before surgery, just after the surgery and one day after surgery
Secondary outcome measures
1. Blood loss during surgery measured by suction device
2. Blood units usage assessed by counting the number of packed cells that have been used during the surgery
3. Ventilation time measured by ventilator machine during and after surgery
4. Kidney damage assessed by blood creatinine level before the intervention (3 days before surgery), just after the surgery and one day after surgery
Overall trial start date
10/09/2017
Overall trial end date
21/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Candidate for first-time elective CABG surgery for coronary artery disease (CAD)
2. Coronary artery surgery only (i.e. no valvular surgery)
3. Cardiopulmonary pump used during surgery
4. Vitamin D level below 30 ng/ml
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66
Total final enrolment
70
Participant exclusion criteria
1. Renal failure or creatinine level >1.5 mg/dl
2. Previous use of vitamin D supplement
Recruitment start date
20/10/2018
Recruitment end date
23/12/2018
Locations
Countries of recruitment
Iran
Trial participating centre
Shahid Modarres Hospital
Saadat Abad
Tehran
1153733163
Iran
Funders
Funder type
Other
Funder name
investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data sets including demographic, preoperative and postoperative ones will be available after results publication. All data sets can be shared, if the recipients mention this study in their project. Any kind of analysis can be performed on these data sets. There was no need for patient consent, because all data sets are in codes and have no patient names in them. Anyone who needs the data sets can send a request form to Dr Mahnoosh Foroughi (mahnoosh.foroughi@gmail.com).
Intention to publish date
31/03/2020
Participant level data
Stored in repository
Basic results (scientific)
Publication list