Condition category
Circulatory System
Date applied
17/11/2018
Date assigned
10/12/2018
Last edited
10/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

Sponsor information

Organisation

Shahid Beheshti University of Medical Sciences

Sponsor details

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

Sponsor type

University/education

Website

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

21/05/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes