VItamiN D replacement to prevent Acute Lung injury following OesophagectOmy (VINDALOO-2)

Completed

• Conditions: Oesphageal cancer, acute lung injury; Cancer; Malignant neoplasm of oesophagus

• Registration Number: ISRCTN27673620
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782429 2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30222631

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-21
• Study Completion: 2014-04-01
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Planned transthoracic oesophagectomy for oesophageal carcinoma at a participating centre
2. Aged over 18 years on day of first dose of investigational medicinal product (IMP)
3. Ability to give written informed consent to participate in the study

Exclusion Criteria

1. Known intolerance of vitamin D
2. Known sarcoidosis, hyperparathyroidism, or nephrolithiasis
3. Taking more than 1000iu/day vitamin D supplementation in the month preceding enrolment
4. Baseline serum corrected calcium >2.65 mmol/L
5. Undergoing haemodialysis
6. Pregnant or breastfeeding
7. Taking cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
8. Taking oral preparation containing > 10 micrograms vitamin D/day up to 2 months before first dose of IMP
9. Diagnosis of COPD with an FEV1 less than 50% predicted or resting oxygen saturations of less 92%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extravascular lung water index (EVLWI) at the end of oesophagectomy

Secondary Outcome Measures

Name	Time	Method
Clinical markers indicative of lung injury: <br>1. P:F ratio<br>2. Oxygenation index<br>3. Development of lung injury / ARDS day 0-28<br>4. Duration of ventilation and organ failure, survival <br>5. Safety and tolerability of vitamin D supplementation<br>6. Plasma indices of endothelial and alveolar epithelial function/ injury<br>7. Plasma inflammatory response<br>8. Plasma LL-37 levels<br>9. Plasma vitamin D status (25D3, 1,25D3 and VDBP) <br>10. EVLWI post-operative day 1