- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05376774
Prediction Model of Vitamin D Deficiency
Prediction Model of Vitamin D Deficiency in Critically Ill Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Taipei City, Taiwan, 100
- Department of Anesthesiology, National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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]
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Critically ill patients
Patients admitted to intensive care units
|
Admitted to intensive care units
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance of the score-based prediction model
Time Frame: 1 day
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202203073RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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