Prevalence of Deficiency of Vitamin D in Critically Ill Patients

Completed

• Conditions: Vitamin D Deficiency; Critical Illness

• Registration Number: NCT03639584
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-21
• Study Start: 2018-08-23
• Primary Completion: 2020-07-30
• Study Completion: 2020-11-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 662

Inclusion Criteria

• All ICU patients

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prevalence of Vitamin D deficiency	1 day at enrollment	Investigate the prevalence of vitamin D deficiency among groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan