Validation of Prediction Model of Vitamin D Deficiency

Recruiting

• Conditions: Critical Illness
• Interventions: Other: Admitted to intensive care units

• Registration Number: NCT05094388
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Many studies have pointed out that patients with vitamin D deficiency have a longer stay in the intensive care unit and a poor prognosis. The investigators' previous multi-center prospective observational study in Taiwan reveals that the prevalence of vitamin D deficiency in critically ill patients in northern Taiwan is 59%, and the prevalence of severe vitamin D deficiency is 18%. The investigators used the data of that observational study to train a predictive model for predicting vitamin D deficiency. In addition, the association between vitamin D and the immune regulation of critically ill patients in Taiwan has not been investigated. This study aims primarily to validate the performance of the prediction model of vitamin D deficiency. Moreover, this study will investigate the association between vitamin D level and inflammatory cytokine levels.

This multi-center prospective observational study will enroll critically ill patients admitted to intensive care units (ICUs) less than 28 days. After inform consent, blood will be drawn for examination of vitamin D, interleukin 6, and interleukin 10 levels. The main diagnosis of ICU admission, past medical history, vital signs within 24 hours of admission, disease severity, and laboratory data will be recorded. The predictive model will use the required parameters to predict the patient's risk of vitamin D deficiency and vitamin D severe deficiency.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-26
• Study Start: 2021-11-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients admitted to intensive care units

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Exclusion Criteria

• aged < 20 years
• admitted to intensive care unit longer than 28 days
• body max index < 18 kg/m2
• receive vitamin D supplement > 3000 IU/day
• previously admitted to intensive care unit within 3 months
• have parathyroid disease, rickets, or severe liver cirrhosis [Child C]

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill patients	Admitted to intensive care units	Patients admitted to intensive care units

Primary Outcome Measures

Name	Time	Method
Area under the receiver operating characteristic	1 day	Area under the receiver operating characteristic of the prediction model of vitamin D deficiency

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan