Validation of Prediction Model of Vitamin D Deficiency

NCT ID: NCT05094388

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-10

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill patients

Patients admitted to intensive care units

Admitted to intensive care units

Intervention Type OTHER

Admitted to intensive care units

Interventions

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Admitted to intensive care units

Admitted to intensive care units

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to intensive care units

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 \[Child C\]
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Chang Yeh, MD, PhD

Role: CONTACT

+886-9-68661829

Facility Contacts

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Yu-Chang Yeh, MD, PhD

Role: primary

+886-968661829

Other Identifiers

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202106128RIND

Identifier Type: -

Identifier Source: org_study_id

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