Validation of Prediction Model of Vitamin D Deficiency

NCT05094388 | Recruiting

• 1 other identifier: 202106128RIND
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

critical care; vitamin D

Outcome Measures

Primary Outcomes (1)

• Area under the receiver operating characteristic

  Area under the receiver operating characteristic of the prediction model of vitamin D deficiency

  1 day

Study Arms (1)

Critically ill patients

Patients admitted to intensive care units

Other: Admitted to intensive care units

Interventions

Admitted to intensive care units OTHER

Admitted to intensive care units

Critically ill patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted to intensive care units

You may qualify if:

• Patients admitted to intensive care units

You may not qualify if:

• 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 \[Child C\]

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yu-Chang Yeh, MD, PhD

CONTACT

+886-9-68661829; tonyyeh@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 26, 2021
• Study Start: November 10, 2021
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)