Can vitamin D reduce heart muscle damage after bypass surgery?
| ISRCTN | ISRCTN44896820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44896820 |
| Secondary identifying numbers | 1372 |
- Submission date
- 17/11/2018
- Registration date
- 10/12/2018
- Last edited
- 07/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Saadat Abad Boulevard
District 2
Tehran
1153733163
Iran
 ORCID ID |
0000-0003-2146-7083 |
|---|
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Association between vitamin D administration and cardiac cell pathology in patients undergoing CABG surgery |
| Study objectives | Vitamin D administration in patients with vitamin D deficiency affect pathological features of cardiac muscle cells. |
| Ethics approval(s) | Ethics committee of Shahid Beheshti Medical University, 04/11/2018, ref: IR.SBMU.RETECH.REC.1397.616 |
| Health condition(s) or problem(s) studied | Prevention of cardiomyopathy following CABG surgery |
| 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 |
| 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 study start date | 10/09/2017 |
| Completion date | 21/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 66 |
| Total final enrolment | 70 |
| Key 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 |
| Key exclusion criteria | 1. Renal failure or creatinine level >1.5 mg/dl 2. Previous use of vitamin D supplement |
| Date of first enrolment | 20/10/2018 |
| Date of final enrolment | 23/12/2018 |
Locations
Countries of recruitment
- Iran
Study participating centre
Tehran
1153733163
Iran
Sponsor information
University/education
Deputy of Research of School of Medicine
7th Floor, Bldg No.2
Shahid Beheshti University of Medical Sciences
Arabi Ave
Velenjak
Tehran
19839-63113
Iran
"ROR" |
https://ror.org/034m2b326 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2020 | 07/09/2020 | Yes | No |
Editorial Notes
07/09/2020: Publication reference added.
29/01/2020: The intention to publish date has been changed from 21/05/2019 to 31/03/2020.
18/11/2019: Total final enrolment number added.
