Prediction Model of Vitamin D Deficiency

Critical Illness Clinical Trial

Official title:

Prediction Model of Vitamin D Deficiency in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376774
• Other study ID #: 202203073RIND
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: National Taiwan University Hospital
• Contact: n/a
• 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. 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%. Several prediction models of vitamin D deficiency had been built for the general population but not patients admitted in intensive care units.

This multi-center retrospective study aims to develop and validate a score-based prediction model for severe vitamin D deficiency in critically ill patients. Investigators will review the data of previous multicenter, prospective, observational study. For temporal validation, the data will be divided into a derivation cohort (first 80% of the data set based on chronology) and a validation cohort (the remaining data set). The development and validation of the models will be carried out following the recommendations established in the Transparency Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) initiative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• 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	Department of Anesthesiology, National Taiwan University Hospital	Taipei City

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	Performance of the score-based prediction model	Area under the receiver operating characteristic (AUROC) and area under precision recall curve (AUPRC) of the prediction models for severe vitamin D deficiency	1 day