vitamin D replacement to prevent lung injury following oesophagectomy

• Research type

  Research Study

• Full title

  vitamin D replacement to prevent lung injury following oesophagectomy - a randomised controlled trial.

• IRAS ID

  91021

• Contact name

  David Thickett

• Eudract number

  2012-000332-25

• ISRCTN Number

  ISRCTN27673620

• Research summary

  Sometimes following the operation you are about to undergo, the lungs become inflamed - a condition that is called acute lung injury. This happens about 28% of the time following oesophagectomy and the causes for it are poorly understood. The condition can range in severity from causing mild breathlessness to more severe breathlessness that can require assistance from a ventilator (breathing machine) to help with breathing in intensive care. We believe that people who are severely vitamin D deficient may be more at risk of acute lung injury than those who are not following the operation. We have previously done research which suggests that people who need an oesophagectomy are usually vitamin D deficient with about half being very deficient. We have evidence from our previous studies that those with the lowest levels of vitamin D may be at increased risk of inflammation and post-operative lung problems (acute lung injury). We gratefully acknowledge the help of the 50 patients who have taken part in our preliminary study without which these studies would not have happened. The aim of this study is to work out whether replacing vitamin D with a single dose of liquid vitamin D before the operation reduces evidence of lung damage after the operation. Half of the patients recruited to the study will get a dose of vitamin D (100,000 IU units) which is 5 mls of liquid or an identical dummy drug (known as placebo). This is part of a programme of research funded by the Medical Research Council and will guide us as to the value of undertaking a larger trial to prove that this has approach has major health advantages. This study will also look at markers in the blood and lungs and genetic material from blood and lung cells in an optional translational science study. The samples taken by this study through increasing our understanding of the inflammatory processes it may be possible to identify other potential treatments that could improve outcomes in patients with this condition, or stop it developing at all.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  12/WM/0092

• Date of REC Opinion

  2 May 2012

• REC opinion

  Further Information Favourable Opinion