Table 1.
Frequency and scope of study visits
|
Assessment |
Screening (V0) | Enrolment, baseline data (V1) | Clinical data (V2) |
28-day mortality (V3) | 90-day follow-up (V4) | 1-year follow-up (V5) |
| Day 0 | Day 5 | Day 28 | Day 90 | Month 12 | ||
| Inclusion/exclusion criteria | X | X | ||||
| Informed consent | X | |||||
| Demographics | X | |||||
| Randomisation | X | |||||
| Intervention | ||||||
| Loading dose 540 000 IU vitamin D3 |
X | |||||
| Daily dose 4000 IU vitamin D3 | X | X | X | |||
| Outcome variables | ||||||
| Mortality | X | X | X | X | ||
| SOFA | X | X | ||||
| Infections requiring antibiotics | X | |||||
| Hospital and ICU readmission | X | |||||
| Katz activity of daily life | X | X | ||||
| Safety evaluation | ||||||
| Serum calcium | X | X | X | |||
| Falls/fractures | X | |||||
| New episodes of nephrolithiasis | X | |||||
| Creatinine | X |
ICU, intensive care unit; SOFA, Sequential Organ Function Assessment.