vitamin d open label replacement oesophagectomy.

• Research type

  Research Study

• Full title

  An open label dose ranging study to optimise vitamin D levels prior to oesophagectomy

• IRAS ID

  85430

• Contact name

  David Thickett

• Eudract number

  2011-004199-12

• ISRCTN Number

  na

• Research summary

  this study is an open labelled pharmacokinetic assessment to ascertain the effectiveness and tolerability of preoperative vitamin D supplementation upon plasma vitamin D levels. In a dose escalation study we will give oral liquid vitamin D3 (Vigantol liquid 20000 IU /ml, Merck) initially at 100,000, rising to 200000 then 300000 IU depending upon efficacy. Each dose will be tested in 6 individuals with vitamin D given 7 days prior to the operation date for oesophagectomy. 25D3 levels will be assessed at the end of each dosing phase with progress to next dose escalation dependent upon whether the primary outcome is met by the previous dose.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  11/WM/0330

• Date of REC Opinion

  4 Nov 2011

• REC opinion

  Further Information Favourable Opinion