Vitamin D for prevention of sternotomy healing complications: REINFORCE-D trial.

What Was Tested

This randomized controlled trial looks at Vitamin D, K2, Magnesium and Zinc.

The primary objective of this clinical trial is to compare the incidence of all postoperative sternotomy healing complications in two parallel patient groups administered cholecalciferol or placebo.

Why It Was Studied

Most cardiac surgery patients undergo median sternotomy during open heart surgery.

Sternotomy healing is an arduous, very complex, and multifactorial process dependent on many independent factors affecting the sternum and the surrounding soft tissues.

Who Took Part

The abstract describes 600 patients taking part.

PubMed tags the participants as both men and women.

Males and females from 18 to 95 years of age who fulfill the indication criteria for undergoing cardiac surgery with median sternotomy can be included in this clinical trial, if they meet the eligibility criteria.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Neither the patients nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

Some patients received a placebo instead of Vitamin D, K2, Magnesium and Zinc, giving a reference point.

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

What Was Measured

The secondary objectives are focused on general patient recovery process: sternal bone healing grade at the end of the trial, length of hospitalization, number of days spent in the ICU, number of days spent on mechanical lung ventilation, and number of hospital readmissions for sternotomy complications.

PubMed files the paper under topics including Cardiac Surgical Procedures, Postoperative Complications, Sternotomy, Vitamin D and Wound Healing.

Author keywords: Cardiac surgery, Cholecalciferol, Healing complications, Randomized clinical trial and Trial design.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 600 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 2 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2020 (Trials), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.