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Health Condition(s) or Problem
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Oesphageal cancer, acute lung injury
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Lay Summary
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Not provided at time of registration (from ISRCTN)
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Who can enter the trial
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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
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Who cannot enter the trial
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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%
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What will happen
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Oral vitamin D liquid (100,000 IU) versus identical placebo
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Primary aim
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Extravascular lung water index (EVLWI) at the end of oesophagectomy
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Secondary Aim
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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
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Participant Information Sheet
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Not available in web format, please use the contact details below to request a patient information sheet
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Birmingham
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