Validation of Prediction Model of Vitamin D Deficiency

Critical Illness Clinical Trial

Official title:

Validation of Prediction Model of Vitamin D Deficiency in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094388
• Other study ID #: 202106128RIND
• Status: Recruiting
• Start date: November 10, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: National Taiwan University Hospital
• Contact: Yu-Chang Yeh, MD, PhD
• Phone: +886-9-68661829
• Email: tonyyeh[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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]

Related Conditions & MeSH terms

• Critical Illness
• Vitamin D Deficiency

Intervention

Other:
• Admitted to intensive care units
Admitted to intensive care units

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the receiver operating characteristic	Area under the receiver operating characteristic of the prediction model of vitamin D deficiency	1 day