EXCLUSION CRITERIA

If any of the following apply, the patient is not eligible to be randomised into the VITDALIZE UK Trial:
1. Severe gastrointestinal dysfunction (>400ml nasogastric tube residual volume) /unable to receive trial medication
2. Not expected to survive initial 48 hours of admission or treatment withdrawal imminent within 24 hours.
3. Patients with DNAR (Do Not Attempt Resuscitation) orders in place
4. Hypercalcemia (>2.65mmol/l corrected calcium and/or >1.35mmol/l ionized calcium at screening)
5. Known kidney stones within the last 12 months
6. Known active tuberculosis within the last 12 months
7. Known sarcoidosis within the last 12 months
8. Women of child bearing age who have tested positive for pregnancy or who are lactating
9. Known hypersensitivity to the trial drug or excipient
10. Medical team deem it not suitable to include patient
11. Known prisoners in the custody of HM Prison and Probation Services

Notes on Exclusion Criteria
Criterion 1 is intended to exclude patients who may not absorb the trial medication as it is a per oral or nasogastric tube dosing regimen which cannot be given parenterally. Criteria 2 and 3 are intended to exclude patients unlikely to survive to day 28 primary trial endpoint. Criteria 4, 5, 6, 7 and 9 are intended to exclude patients who may be at higher risk of side effects secondary to high dose vitamin D supplementation. Criterion 8 is to exclude patients as the potential side effects of high dose vitamin D replacement on the foetus are unknown. Criterion 10 is to exclude patients who may suffer severe physical or mental capacity issues and are unlikely to comply with the daily dosing of vitamin D to 90 days.