K Arm of the Effect of High-Dose Vitamin D3 on 28-Day Mortality in Adult Critically Ill Patients with Severe Vitamin D Deficiency.

Phase 1

• Conditions: Critically ill patients who are in intensive care and are found to be severely vitamin D deficient (25(OH)D =12ng/ml (30nmol/L)).; MedDRA version: 21.1Level: PTClassification code 10059936Term: Blood 25-hydroxycholecalciferolSystem Organ Class: 10022891 - Investigations; MedDRA version: 21.1Level: PTClassification code 10053813Term: Blood 25-hydroxycholecalciferol decreasedSystem Organ Class: 10022891 - Investigations; MedDRA version: 21.0Level: LLTClassification code 10080368Term: Vitamin D3 deficiencySystem Organ Class: 100000004861; MedDRA version: 20.0Level: PTClassification code 10077264Term: Critical illnessSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2016-002460-13-GB
• Lead Sponsor: Medical Unviersity of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-25
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 =12ng/ml (30nmol/L)) using either the hospital's clinical laboratory or rapid bedside testing after ICU admission

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

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. Patient 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified