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

Trials. 2013 Apr 17;14:100. doi: 10.1186/1745-6215-14-100.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Lung Injury / blood
  • Acute Lung Injury / etiology
  • Acute Lung Injury / mortality
  • Acute Lung Injury / prevention & control*
  • Administration, Oral
  • Biomarkers / blood
  • Clinical Protocols
  • Double-Blind Method
  • Drug Administration Schedule
  • Elective Surgical Procedures
  • Esophagectomy / adverse effects*
  • Esophagectomy / mortality
  • Humans
  • Pulmonary Edema / etiology
  • Pulmonary Edema / prevention & control
  • Research Design*
  • Respiration, Artificial
  • Time Factors
  • Treatment Outcome
  • United Kingdom
  • Vitamin D / administration & dosage*
  • Vitamin D / blood


  • Biomarkers
  • Vitamin D

Associated data

  • ISRCTN/ISRCTN27673620