Oesphageal cancer, acute lung injury Cancer Malignant neoplasm of oesophagus
Conditions
Interventions
Oral vitamin D liquid (100,000 IU) versus identical placebo
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extravascular lung water index (EVLWI) at the end of oesophagectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical markers indicative of lung injury: 1. P:F ratio 2. Oxygenation index 3. Development of lung injury / ARDS day 0-28 4. Duration of ventilation and organ failure, survival 5. Safety and tolerability of vitamin D supplementation 6. Plasma indices of endothelial and alveolar epithelial function/ injury 7. Plasma inflammatory response 8. Plasma LL-37 levels 9. Plasma vitamin D status (25D3, 1,25D3 and VDBP) 10. EVLWI post-operative day 1 | — |
Countries
United Kingdom
Outcome results
None listed