Oesophageal cancer/acute lung injury/oesophagecetomy Cancer Malignant neoplasm of oesophagus
Conditions
Interventions
Patients will be given a single dose of oral Vigantol® liquid approximately 7 days preoperatively.
Doses will be 100,000 units, 200,000 units or 300,000 units of vitamin D.
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 16 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 chronic obstructive pulmonary disease (COPD) with an forced expiratory volume in one second (FEV1) less than 50% predicted or resting oxygen saturations of less 92%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dose of Vigantol® that successfully increases serum vitamin D levels above 75 nmol/l in all cases | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability data - blood biochemistry, medication related side effects 2. Plasma 25D3 levels at 7, 10 and 14 days post dose 3. Plasma LL-37 (a downstream vitamin D target) at baseline and on the day of operation 4. Change in Plasma 1, 25 D3 (the biologically active hormone) from baseline on the day of operation | — |
Countries
United Kingdom
Outcome results
None listed