VITdAL@ICU - Correction of Vitamin D Deficiency in Critically Ill Patients

Study Overview
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Brief Summary
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Study hypothesis: High-dose vitamin D leads to a shorter hospital stay in critically ill patients Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo.

Detailed Description
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Inclusion criteria Age ≥18 years expected ICU stay ≥48 hours vitamin D deficiency: 25(OH)D ≤ 20 ng/ml feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible Exclusion criteria moribund patient expected to die within 24 hours hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l) severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml) known history of recent kidney stones (≤ 1 year) known granulomatous diseases (tuberculosis, sarcoidosis) pregnancy Primary endpoint hospital stay (hours; starting from ICU admission) Secondary endpoints percentage of patients with 25(OH)D ≥ 30 ng/ml at day 7 serum calcium; phosphorus; 25(OH)D; 1,25(OH)D; PTH; osteocalcin; bALP; TRAP; urinary calcium

Official Title
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Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial (VITDAL@ICU)

Conditions
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Critical Illness, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Cholecalciferol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years expected ICU stay ≥48 hours vitamin D deficiency: 25(OH)D ≤ 20 ng/ml feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible Exclusion Criteria: moribund patient expected to die within 24 hours hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l) severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml) known history of recent kidney stones (≤ 1 year) known granulomatous diseases (tuberculosis, sarcoidosis) pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholecalciferol<br> | Drug: Cholecalciferol<br>* loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo<br>* Other names: herbal oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The length of hospital stay will be compared between the two groups (starting from application of the study medication; end is defined as death of the patient or hospital discharge) Survivors and non-survivors will also be analysed separately. Stay in rehabilitation facilities will not be counted. | maximum 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25(OH)D levels | serum 25(OH)D levels will be measured on day 0, 3 and 7 | maximum 6 months | 
| calcium levels | serum calcium levels will be measured on day 0, 3 and 7 | maximum 6 months | 
| length of ICU stay starting from application of study medication |  | until patient's death or referral to another ward | 
| duration of mechanical ventilation | duration of mechanical ventilation including CPAP/mask ventilation | starting from application of study medication | 
| hospital mortality, 28-day mortality, 6 month-mortality |  | maximum 6 months |