Prevalence of Deficiency of Vitamin D in Critically Ill Patients

NCT ID: NCT03639584

Last Updated: 2021-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

662 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-23

Study Completion Date

2020-11-30

Brief Summary

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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 .

Detailed Description

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Studies have revealed that the serum level of 25-hydroxyvitamin D, as known as calcidiol, is low in critically ill patients. The prevalence ranges from 26 to 82%. 25-hydroxyvitamin D deficiency is associated with longer ICU stay, higher medical cost and higher death rate in septic patients. 25-hydroxyvitamin D is a kind of hormone related to bone and mineral metabolism. Moreover, the receptors were found in almost all cells, and it is related to immune system, cytokine release, cellular proliferation and differentiation, angiogenesis, and muscular energy. The main source is skin metabolism triggered by sunshine and food consumption. It is subsequently converted to calcifediol in the liver and then calcitriol in the kidney (the active form). Its serum level is regulated by parathyroid hormone and serum calcium and phosphate. The critically ill patients are deprived of sunshine, suffered from poor nutrition support, impaired liver and kidney function, higher rate of consumption, and are under higher risk of deficiency. Nowadays, the studies about 25-hydroxyvitamin D in ICU patients were conducted mostly in Europe and America. There is no large-scale study in Taiwan or Asia. A randomized controlled study from Austria has shown large dose supply in patients with 25-hydroxyvitamin D deficiency could decrease the mortality.

The object of this multi-center study is to investigate the prevalence of 25-hydroxyvitamin D deficiency, the risk factors and the correlation with outcomes. The results could be a step-stone for future randomized controlled studies.

Conditions

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Vitamin D Deficiency Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Group 3

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

No interventions assigned to this group

Group 4

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

No interventions assigned to this group

Group 5

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All ICU patients

Exclusion Criteria

* 1, 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chung-Wei Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Li-Kuo Kuo, MD

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Kuo-Ching Yuan, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 36544226 (View on PubMed)

Other Identifiers

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201805087RINB

Identifier Type: -

Identifier Source: org_study_id

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