Can Vitamin D Reduce Heart Muscle Damage After Bypass Surgery?
Condition: Vitamin D Deficiency; Cardiomyopathies; Apoptosis; Inflammation
MeSH terms: Cardiomyopathies; Vitamin D Deficiency; Inflammation
Intervention: Vitamin D; Placebo
Intervention description: 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; Placebo
Intervention MeSH terms: Vitamin D
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: With the exception of the pharmacists, all the investigators, patients and the medical team were blinded to the group allocation.
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin D; Cardiovascular disease; Apoptosis; Insulin-like growth factor-1; Coronary artery disease; Cardiopulmonary bypass; Interleukin-10

Summary:

      Background and study aim:

      Heart diseases are among the most common causes 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 Grafting (CABG) surgery is a treatment 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
    

Eligibility criteria:

        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

        Exclusion Criteria:

          1. Renal failure or creatinine level >1.5 mg/dl

          2. Previous use of vitamin D supplement