Phase 4
Completed N=70
Can Vitamin D Reduce Heart Muscle Damage After Bypass Surgery?
Source: ClinicalTrials.gov NCT04323852 ↗Enrolled (actual)
70
Serious AEs
12.9%
Results posted
Oct 2021
Primary outcomePrimary: Caspase 2 Enzyme Level — 1.3; 2.0 cells/ HPF
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 [email protected]
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caspase 2 Enzyme Level |
1.3; 2.0 | — |
| PRIMARY Caspase 3 Enzyme Level, an Average of 3 Hours |
1.2; 2.0 | — |
| PRIMARY Caspase 7 Enzyme Level |
1.3; 1.8 | — |
| PRIMARY Interlukin-10 (IL-10) Serum Level |
1.0; 1.0 | — |
| PRIMARY Interleukin-10 (IL-10) Serum Level |
4.4; 1.0 | — |
| PRIMARY Interleukin--10 (IL-10) Serum Level |
304.8; 205.5 | — |
| PRIMARY Interleukin (IL-10) Serum Level |
7.6; 4.0 | — |
| PRIMARY Insulin Growth Factor |
108.6; 69.4 | — |
| PRIMARY Insulin Growth Factor |
108.6; 69.4 | — |
| PRIMARY Insulin Growth Factor |
108.6; 69.4 | — |
| PRIMARY Insulin Growth Factor |
108.6; 69.4 | — |
| SECONDARY Hemorrhage After Surgery |
360.7; 404.4 | — |
| SECONDARY Blood Units Usage |
0.5; 0.8 | — |
| SECONDARY Ventilator Application |
6.8; 8.3 | — |
| SECONDARY Creatinine Level |
.8; .9 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Renal failure or creatinine level >1.5 mg/dl
- Previous use of vitamin D supplement
Data sourced from ClinicalTrials.gov (NCT04323852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.