Vitamin D to prevent acute lung injury following oesophagectomy (VINDALOO): study protocol for a randomised placebo controlled trial
1 College of Medical and Dental Sciences, University of Birmingham, Vincent Drive, Birmingham B15 2TT, UK
2 Warwick Medical School Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Warwick, Coventry CV4 7AL, UK
3 Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, St Dunstan’s Road, London E1 2AB, UK
4 Norwich Medical School, University of East Anglia, University Drive, Norwich NR4 7TJ, UK
Trials 2013, 14:100 doi:10.1186/1745-6215-14-100Published: 17 April 2013
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.
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.
This study will ascertain whether vitamin D replacement alters biomarkers of lung damage following oesophagectomy.
Current Controlled Trials ISRCTN27673620