Prediction Model of Vitamin D Deficiency

September 11, 2022 updated by: National Taiwan University Hospital

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

662

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei City, Taiwan, 100
        • Department of Anesthesiology, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 11, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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