title: Vitamin D to prevent acute lung injury following oesophagectomy (VINDALOO): study protocol for a randomised placebo controlled trial.
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® 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.
  
  
  CONCLUSIONS
  This study will ascertain whether vitamin D replacement alters biomarkers of lung damage following oesophagectomy.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN27673620.
authors.forename: Dhruv
authors.initials: D
authors.lastname: Parekh
authors.forename: Rachel C A
authors.initials: RC
authors.lastname: Dancer
authors.forename: Sian
authors.initials: S
authors.lastname: Lax
authors.forename: Mark S
authors.initials: MS
authors.lastname: Cooper
authors.forename: Adrian R
authors.initials: AR
authors.lastname: Martineau
authors.forename: William D
authors.initials: WD
authors.lastname: Fraser
authors.forename: Olga
authors.initials: O
authors.lastname: Tucker
authors.forename: Derek
authors.initials: D
authors.lastname: Alderson
authors.forename: Gavin D
authors.initials: GD
authors.lastname: Perkins
authors.forename: Fang
authors.initials: F
authors.lastname: Gao-Smith
authors.forename: David R
authors.initials: DR
authors.lastname: Thickett
mesh_terms: D055371:Acute Lung Injury / Q000097:blood / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D000284:Administration, Oral; D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D017558:Elective Surgical Procedures; D016629:Esophagectomy / Q000009:adverse effects* / Q000401:mortality; D006801:Humans; D011654:Pulmonary Edema / Q000209:etiology / Q000517:prevention & control; D012107:Research Design; D012121:Respiration, Artificial; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014807:Vitamin D / Q000008:administration & dosage* / Q000097:blood
chemical_list: D015415:Biomarkers; D014807:Vitamin D