Last reviewed · How we verify

NCT04323852

Can Vitamin D Reduce Heart Muscle Damage After Bypass Surgery?

Completed Phase 4 Results posted Last updated 19 October 2021
What this trial tests

Phase 4 trial testing Vitamin D in Vitamin D Deficiency in 70 participants. Completed in 21 January 2019.

Timeline
1 September 2017
Primary endpoint
1 December 2018
21 January 2019

Quick facts

Lead sponsorShahid Beheshti University of Medical Sciences
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment70
Start date1 September 2017
Primary completion1 December 2018
Estimated completion21 January 2019
Sites1 location across Iran

Drugs / interventions tested

Conditions studied

Sponsor

Shahid Beheshti University of Medical Sciences

Who can join

18 and older, any sex, with Vitamin D Deficiency or Cardiomyopathies. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Caspase 2 Enzyme Level Primary · during the surgery, an average of 3 hours

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.

GroupValue95% CI
Vitamin D1.3± 1.0
Control Group2.0± 0.9
Caspase 3 Enzyme Level, an Average of 3 Hours Primary · during the surgery, 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.

GroupValue95% CI
Vitamin D1.2± 0.8
Control Group2.0± 0.8
Caspase 7 Enzyme Level Primary · during the surgery, an average of 3 hours

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.

GroupValue95% CI
Vitamin D1.3± 1.0
Control Group1.8± 1.2
Interlukin-10 (IL-10) Serum Level Primary · Right before the intervention(3 days before surgery)

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

GroupValue95% CI
Vitamin D1.0± 0.35
Control Group1.0± 0
Interleukin-10 (IL-10) Serum Level Primary · procedure (before anesthesia induction)

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

GroupValue95% CI
Vitamin D4.4± 4.9
Control Group1.0± 0
Interleukin--10 (IL-10) Serum Level Primary · at the end of surgery after protamine reversal

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

GroupValue95% CI
Vitamin D304.8± 85.6
Control Group205.5± 107.4
Interleukin (IL-10) Serum Level Primary · the first postoperative day

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

GroupValue95% CI
Vitamin D7.6± 6.5
Control Group4.0± 6.7
Insulin Growth Factor Primary · Right before the intervention(3 days before surgery)

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

GroupValue95% CI
Vitamin D86.3± 33.9
Control Group76.5± 26.6
Insulin Growth Factor Primary · procedure (before anesthesia induction)

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

GroupValue95% CI
Vitamin D109.8± 63.2
Control Group75.0± 21.3
Insulin Growth Factor Primary · at the end of surgery after protamine reversal

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

GroupValue95% CI
Vitamin D142.0± 67.1
Control Group82.1± 35.9
Insulin Growth Factor Primary · the first postoperative day

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

GroupValue95% CI
Vitamin D108.6± 61.2
Control Group69.4± 35.4
Hemorrhage After Surgery Secondary · immediately after surgery

after the surgery all the hemorrhage of patients was collected by suctioning and the exact amount of bleeding has been reported.

GroupValue95% CI
Vitamin D360.7± 237.7
Control Group404.4± 245.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vitamin D
Serious: 4/35 (11%)
Deaths: 0/35
Control Group
Serious: 5/35 (14%)
Deaths: 0/35

Serious adverse events (3 terms)

ReactionSystemVitamin DControl Group
brain strokeNervous system disorders
heart attackCardiac disorders
gastrointestinal bleedingGastrointestinal disorders
Other adverse events (2 terms — click to expand)

ReactionSystemVitamin DControl Group
infectionImmune system disorders
DVTVascular disorders

Most-reported serious reactions: brain stroke, heart attack, gastrointestinal bleeding.

Data from ClinicalTrials.gov NCT04323852 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Current Knowledge of the Impact of Vitamin D in Coronary Artery Disease.
    Jespersen FE, Grimm D, Krüger M, Wehland M. · · 2025 · cited 3× · PMID 40507812 · DOI 10.3390/ijms26115002

Verify or expand the search:

Other trials of Vitamin D

Trials testing the same drug.

Other recruiting trials for Vitamin D Deficiency

Currently open trials in the same condition.

Other Shahid Beheshti University of Medical Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04323852.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing