CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Vitamin D +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04323852
NCT04323852Phase 4Completed

Vitamin D Treatment Attenuates Heart Apoptosis After Coronary Artery Bypass Surgery; A Double-Blind Randomized Placebo-Controlled Clinical Trial

Shahid Beheshti University of Medical Sciences·interventional·Posted Mar 27, 2020·Updated Oct 19, 2021

In Brief

A Phase 4 clinical trial evaluating Vitamin D and Placebo for Vitamin D Deficiency and 3 related conditions. Completed, enrolled 70 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIran
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 27, 2020
Enrollment StartSep 1, 2017
Primary CompletionDec 1, 2018
Study CompletionJan 21, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.3 years ago

Interventions

Vitamin Ddrug

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

Placebodrug

Placebo