Prevalence of Deficiency of Vitamin D in Critically Ill Patients

Study Overview
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Brief Summary
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Vitamin D has been shown to related to clinical outcomes in critically ill patients. The object of this study is to investigate the prevalence of Vitamin D deficiency in critically ill patients with various length of ICU stay .

Detailed Description
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Studies have revealed that the serum level of 25-hydroxyvitamin D, as known as calcidiol, is low in critically ill patients. The prevalence ranges from 26 to 82%. 25-hydroxyvitamin D deficiency is associated with longer ICU stay, higher medical cost and higher death rate in septic patients. 25-hydroxyvitamin D is a kind of hormone related to bone and mineral metabolism. Moreover, the receptors were found in almost all cells, and it is related to immune system, cytokine release, cellular proliferation and differentiation, angiogenesis, and muscular energy. The main source is skin metabolism triggered by sunshine and food consumption. It is subsequently converted to calcifediol in the liver and then calcitriol in the kidney (the active form). Its serum level is regulated by parathyroid hormone and serum calcium and phosphate. The critically ill patients are deprived of sunshine, suffered from poor nutrition support, impaired liver and kidney function, higher rate of consumption, and are under higher risk of deficiency. Nowadays, the studies about 25-hydroxyvitamin D in ICU patients were conducted mostly in Europe and America. There is no large-scale study in Taiwan or Asia. A randomized controlled study from Austria has shown large dose supply in patients with 25-hydroxyvitamin D deficiency could decrease the mortality. The object of this multi-center study is to investigate the prevalence of 25-hydroxyvitamin D deficiency, the risk factors and the correlation with outcomes. The results could be a step-stone for future randomized controlled studies.

Official Title
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Investigating the Prevalence of Deficiency of Vitamin D in Critically Ill Patients and Its Effects on the Prognosis

Conditions
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Vitamin D Deficiency, Critical Illness

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All ICU patients Exclusion Criteria: 1, Less than 20 years 2, BMI < 18 kg/m^2 3, Had large dose vit D within previous four weeks (over 3000 IU per day) 4, ICU admission within previous three months 5, Have disease affecting vit D level, calcium metabolism, bone metabolism such as parathyroid disease, Rickets, liver cirrhosis child C 6, Communication difficulty

Ages Eligible for Study
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Minimum Age: 20 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients admitted to ICU less than 48 hours and the anticipated stay is less than 5 days. Take blood sample on the day of enrollment. | |
| Group 2<br>Patients admitted to ICU less than 48 hours and the anticipated stay is longer than 5 days. Take blood sample on the day of enrollment, 7th, 14th, 21st, and 28th. Stop blood sample once exit. | |
| Group 3<br>Patients admitted to ICU 3 7 days. Take blood sample on the day of enrollment. | |
| Group 4<br>Patients admitted to ICU 8 14 days. Take blood sample on the day of enrollment. | |
| Group 5<br>Patients admitted to ICU 15 28 days. Take blood sample on the day of enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of Vitamin D deficiency | Investigate the prevalence of vitamin D deficiency among groups | 1 day at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of mortality on 28th and 90th day in group 2 | Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 2 | 90 days | 
| Difference of mortality on 28th and 90th day in group 3, 4, and 5 | Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 3, 4, and 5 | 90 days | 
| Serial changes of serum vitamin D levels in group 2 | investigate the serum vitamin D levels at different time points in group 2 | 28 days | 
| Difference of 28-day ventialtor-free days | Compare the 28-day ventialtor-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups | 28 days | 
| Difference of 28-day ICU-free days | Compare the 28-day ICU-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D Deficiency, Critical Illness