NCT03639584

Brief Summary

Vitamin D has been shown to related to clinical outcomes in critically ill patients. The object of this study is to investigate the prevalence of Vitamin D deficiency in critically ill patients with various length of ICU stay .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
662

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

August 23, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

August 14, 2018

Last Update Submit

April 20, 2021

Conditions

Keywords

Vitamin D DeficiencyCritical Illness

Outcome Measures

Primary Outcomes (1)

  • The prevalence of Vitamin D deficiency

    Investigate the prevalence of vitamin D deficiency among groups

    1 day at enrollment

Secondary Outcomes (5)

  • Difference of mortality on 28th and 90th day in group 2

    90 days

  • Difference of mortality on 28th and 90th day in group 3, 4, and 5

    90 days

  • Serial changes of serum vitamin D levels in group 2

    28 days

  • Difference of 28-day ventialtor-free days

    28 days

  • Difference of 28-day ICU-free days

    28 days

Study Arms (5)

Group 1

Patients admitted to ICU less than 48 hours and the anticipated stay is less than 5 days. Take blood sample on the day of enrollment.

Group 2

Patients admitted to ICU less than 48 hours and the anticipated stay is longer than 5 days. Take blood sample on the day of enrollment, 7th, 14th, 21st, and 28th. Stop blood sample once exit.

Group 3

Patients admitted to ICU 3\~7 days. Take blood sample on the day of enrollment.

Group 4

Patients admitted to ICU 8\~14 days. Take blood sample on the day of enrollment.

Group 5

Patients admitted to ICU 15\~28 days. Take blood sample on the day of enrollment.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a multi-center, cross-sectional study involving four medical center in Taipei, Taiwan, which are National Taiwan University Hospital (NTUH), Far Eastern Memorial Hospital (FEMH), MacKay Memorial Hospital (MMH), and Taipei Medical University Hospital (TMUH). The target population is all the ICU patients, divided into four groups according to the length of ICU stay. The serum level of vit D, ICU event such as infection, ventilator dependency is to be recorded.

You may qualify if:

  • All ICU patients

You may not qualify if:

  • , Less than 20 years 2, BMI \< 18 kg/m\^2 3, Had large dose vit D within previous four weeks (over 3000 IU per day) 4, ICU admission within previous three months 5, Have disease affecting vit D level, calcium metabolism, bone metabolism such as parathyroid disease, Rickets, liver cirrhosis child C 6, Communication difficulty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • Kuo YT, Kuo LK, Chen CW, Yuan KC, Fu CH, Chiu CT, Yeh YC, Liu JH, Shih MC. Score-based prediction model for severe vitamin D deficiency in patients with critical illness: development and validation. Crit Care. 2022 Dec 21;26(1):394. doi: 10.1186/s13054-022-04274-9.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Vitamin D DeficiencyCritical Illness

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chung-Wei Chen, MD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR
  • Li-Kuo Kuo, MD

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR
  • Kuo-Ching Yuan, MD

    Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 21, 2018

Study Start

August 23, 2018

Primary Completion

July 30, 2020

Study Completion

November 30, 2020

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations