Vitamin D to prevent acute lung injury following oesophagectomy (VINDALOO): study protocol for a randomised placebo controlled trial.

What Was Tested

The paper reports a study of Vitamin D, K2, Magnesium and Zinc, published as a randomized controlled trial.

Who Took Part

The study group was 80 patients.

The trial secondary outcomes are clinical markers indicative of lung injury: PaO2:FiO2 ratio, oxygenation index; development of acute lung injury to day 28; duration of ventilation and organ failure; survival; safety and tolerability of vitamin D supplementation; plasma indices of endothelial and alveolar epithelial function/injury, plasma inflammatory response and plasma vitamin D status.

The study aims to recruit 80 patients from three UK centres.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the patients and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

The comparison arm used a placebo, so changes seen with Vitamin D, K2, Magnesium and Zinc could be set against what happens without it.

The primary outcome will be change in extravascular lung water index measured by PiCCO® transpulmonary thermodilution catheter at the end of the oesophagectomy.

What Was Measured

The subject headings attached to it are Acute Lung Injury, Biomarkers, Clinical Protocols, Elective Surgical Procedures, Esophagectomy, Pulmonary Edema and Respiration, Artificial.

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 80 patients.

The abstract goes on to report its results in about 1 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2013 (Trials), a journal based in England.

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