Can Vitamin D Reduce Heart Muscle Damage After Bypass Surgery?

NCT04323852 | Completed Phase 4 Results

• 3 other identifiers: 13312ISRCTN44896820IRCT20180118038423N1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vitamin D Deficiency; Cardiomyopathies; Apoptosis; Inflammation

Keywords

Vitamin D; Cardiovascular disease; Apoptosis; Insulin-like growth factor-1; Coronary artery disease; Cardiopulmonary bypass; Interleukin-10

Outcome Measures

Primary Outcomes (11)

• Caspase 2 Enzyme Level

  Caspase 2 enzyme activity in right atrial specimen measured by with immunohistochemistry staining The positive control and negative control were taken from human lymph node tissue. as for the control tissue a humane lymph node was used. Positivity for active caspase is shown using cytoplasmic staining . the number of apoptotic cells was measure per each high power filed (HPF) under light microscopy.

  during the surgery, an average of 3 hours

• Caspase 3 Enzyme Level, an Average of 3 Hours

  Caspase 3 enzyme activity in right atrial specimen measured by with immunohistochemistry staining The positive control and negative control were taken from human lymph node tissue. as for the control tissue a humane lymph node was used. Positivity for active caspase is shown using cytoplasmic staining . the number of apoptotic cells was measure per each high power filed (HPF) under light microscopy.

  during the surgery, an average of 3 hours

• Caspase 7 Enzyme Level

  Caspase 7 enzyme activity in right atrial specimen measured by with immunohistochemistry staining The positive control and negative control were taken from human lymph node tissue. as for the control tissue a humane lymph node was used. Positivity for active caspase is shown using cytoplasmic staining . the number of apoptotic cells was measure per each high power filed (HPF) under light microscopy.

  during the surgery, an average of 3 hours

• Interlukin-10 (IL-10) Serum Level

  The concentration of IL-10 in the serum of patients was measured using a quantitative enzyme-linked immunosorbent assay (ELISA) kit .

  Right before the intervention(3 days before surgery)

• Interleukin-10 (IL-10) Serum Level

  The concentration of IL-10 in the serum of patients was measured using a quantitative enzyme-linked immunosorbent assay (ELISA) kit .

  procedure (before anesthesia induction)

• Interleukin--10 (IL-10) Serum Level

  The concentration of IL-10 in the serum of patients was measured using a quantitative enzyme-linked immunosorbent assay (ELISA) kit .

  at the end of surgery after protamine reversal

• Interleukin (IL-10) Serum Level

  The concentration of IL-10 in the serum of patients was measured using a quantitative enzyme-linked immunosorbent assay (ELISA) kit .

  the first postoperative day

• Insulin Growth Factor

  The concentration of the IGF-1 was also measured by a quantitative ELISA kit

  Right before the intervention(3 days before surgery)

• Insulin Growth Factor

  The concentration of the IGF-1 was also measured by a quantitative ELISA kit

  procedure (before anesthesia induction)

• Insulin Growth Factor

  The concentration of the IGF-1 was also measured by a quantitative ELISA kit

  at the end of surgery after protamine reversal

• Insulin Growth Factor

  The concentration of the IGF-1 was also measured by a quantitative ELISA kit

  the first postoperative day

Secondary Outcomes (4)

• Hemorrhage After Surgery

  immediately after surgery

• Blood Units Usage

  discharge 1 day

• Ventilator Application

  discharge 1 day

• Creatinine Level

  immediately after surgery

Study Arms (2)

vitamin D

EXPERIMENTAL

35 patients that pass the inclusion criteria and do not have exclusion criteria that will receive Vitamin D for 3 days and each time 3 doses of 50000 units

Drug: Vitamin D

control group

PLACEBO COMPARATOR

35 patients that will receive placebo for 3 days and each day for 3 doses

Drug: Placebo

Interventions

Vitamin D DRUG

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

vitamin D

Placebo DRUG

Placebo

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate for first-time elective CABG surgery for coronary artery disease (CAD)
• Coronary artery surgery only (i.e. no valvular surgery)
• Cardiopulmonary pump used during surgery
• Vitamin D level below 30 ng/ml

You may not qualify if:

• Renal failure or creatinine level \>1.5 mg/dl
• Previous use of vitamin D supplement

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

modarres Hospital

Tehran, Iran

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Cardiomyopathies; Inflammation; Cardiovascular Diseases; Coronary Artery Disease

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Although this single-center study had a relatively small sample size and was limited to cardiac surgery patients, the study design was RCT with homogenous patients.

Results Point of Contact

• Title: Dr. ََAfshin Zarghi
• Organization: Shahid Beheshti Medical School

Mpajouhesh@sbmu.ac.ir

021-22439781

Study Officials

• Erfan Tasdighi, MD

  Shahid Beheshti university of medical science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: With the exception of the pharmacists, all the investigators, patients and the medical team were blinded to the group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 27, 2020
• Study Start: September 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 21, 2019
• Last Updated: October 19, 2021
• Results First Posted: October 19, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)