VITDALIZE UK: Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency

Not Applicable

• Conditions: Vitamin D deficiency; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN44822292
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-24
• Last Update Posted: 9 January 2023
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

1. Patients = 18 years
2. Anticipated ICU stay = 48 hours
3. Admission to ICU = 72 hours before screening for VDD
4. Severe VDD (25(OH)D = 12 ng/ml [30 nmol/l]) using either the hospital's clinical laboratory or rapid bedside testing after ICU admission

Exclusion Criteria

1. Severe gastrointestinal dysfunction (> 400 ml 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. Patient with DNAR (Do Not Attempt Resuscitation) orders in place
4. Hypercalcemia (> 2.65 mmol/l corrected calcium and/or > 1.35 mmol/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 childbearing 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified