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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: Dhruv Parekh, Rachel C A Dancer, Sian Lax, Mark S Cooper, Adrian R Martineau, William D Fraser, Olga Tucker, Derek Alderson, Gavin D Perkins, Fang Gao-Smith, David R Thickett

Published in: Trials | Issue 1/2013

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Abstract

Background

Acute lung injury occurs in approximately 25% to 30% of subjects undergoing oesophagectomy. Experimental studies suggest that treatment with vitamin D may prevent the development of acute lung injury by decreasing inflammatory cytokine release, enhancing lung epithelial repair and protecting alveolar capillary barrier function.

Methods/Design

The ‘Vitamin D to prevent lung injury following oesophagectomy trial’ is a multi-centre, randomised, double-blind, placebo-controlled trial. The aim of the trial is to determine in patients undergoing elective transthoracic oesophagectomy, if pre-treatment with a single oral dose of vitamin D3 (300,000 IU (7.5 mg) cholecalciferol in oily solution administered seven days pre-operatively) compared to placebo affects biomarkers of early acute lung injury and other clinical outcomes. The primary outcome will be change in extravascular lung water index measured by PiCCO® transpulmonary thermodilution catheter at the end of the oesophagectomy. 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.

Discussion

This study will ascertain whether vitamin D replacement alters biomarkers of lung damage following oesophagectomy.

Trial registration

Current Controlled Trials ISRCTN27673620
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Metadata
Title
Vitamin D to prevent acute lung injury following oesophagectomy (VINDALOO): study protocol for a randomised placebo controlled trial
Authors
Dhruv Parekh
Rachel C A Dancer
Sian Lax
Mark S Cooper
Adrian R Martineau
William D Fraser
Olga Tucker
Derek Alderson
Gavin D Perkins
Fang Gao-Smith
David R Thickett
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-100

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