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

Parekh, Dhruv, Dancer, Rachel C. A., Lax, Sian, Cooper, Mark S., Martineau, Adrian R., Fraser, William D., Tucker, Olga, Alderson, Derek, Perkins, Gavin D., Gao-Smith, Fang and Thickett, David R. (2013) Vitamin D to prevent acute lung injury following oesophagectomy (VINDALOO): Study protocol for a randomised placebo controlled trial. Trials, 14. ISSN 1745-6215

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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: 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(R) 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.

Item Type:	Article
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups:	Faculty of Medicine and Health Sciences > Research Groups > Musculoskeletal Medicine Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health
Depositing User:	Pure Connector
Date Deposited:	25 Sep 2013 01:01
Last Modified:	19 Oct 2023 01:10
URI:	https://ueaeprints.uea.ac.uk/id/eprint/43458
DOI:	10.1186/1745-6215-14-100

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