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Vitamin D for Critically Traumatic Patients

Primary Purpose

Vitamin D Deficiency, Major Trauma

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Major Trauma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major trauma adult (> 20 years old) with Injury Severity Score equal or higher than 16, who is admitted to ICU

Exclusion Criteria:

Patients with the following conditions:

  • Chronic liver disease
  • Contraindication to enteral feeds
  • Hypercalcemia
  • Current use of vitamin D, estrogen, or medications for bone disease
  • High risk of hypercalcemia, ex. metastatic cancer, primary hyperparathyroidism, sarcoidosis, multiple myeloma

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

Experimental group will receive 576,000 IU on the 3rd post-trauma day and 432,000 IU on the 10th post-trauma day (1,008,000 IU in total) theoretically to achieve sufficient level of vitamin D.

Outcomes

Primary Outcome Measures

Mortality
Mortality in ICU

Secondary Outcome Measures

Full Information

First Posted
July 5, 2022
Last Updated
December 6, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05449522
Brief Title
Vitamin D for Critically Traumatic Patients
Official Title
Effects of High Doses of Liquid Vitamin D Supplementation on Clinical Outcomes in Critically Traumatic Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Trauma has been an important global public health issue. Yet it is the sixth cause of death in Taiwan, trauma brings great negative impact to national productivity since it presents specifically as the leading cause of death for the population aged below 40 years. According to the national databank from Formosa Association for the Surgery of Trauma, mortality rate in critically traumatic patients with injury severity score (ISS) ≥ 25 is as high as 23%. Vitamin D, a pleiotropic hormone, regulates directly functions of most organs and immune system. It has been proven that vitamin D insufficiency or deficiency would deteriorate survival of critically ill patients, while supplementation of high-dose vitamin D ameliorates the clinical outcomes. This study investigates whether multiple high doses of vitamin D supplementation in one week can decrease the mortality and morbidity in critically traumatic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Major Trauma
Keywords
Vitamin D, Major Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Experimental group will receive 576,000 IU on the 3rd post-trauma day and 432,000 IU on the 10th post-trauma day (1,008,000 IU in total) theoretically to achieve sufficient level of vitamin D.
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Vitamin D
Intervention Description
High dose of vitamin D is given in divided dose orally or enterally via a feeding tube
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality in ICU
Time Frame
up to 3 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major trauma adult (> 20 years old) with Injury Severity Score equal or higher than 16, who is admitted to ICU Exclusion Criteria: Patients with the following conditions: Chronic liver disease Contraindication to enteral feeds Hypercalcemia Current use of vitamin D, estrogen, or medications for bone disease High risk of hypercalcemia, ex. metastatic cancer, primary hyperparathyroidism, sarcoidosis, multiple myeloma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yin-Yi Han, MD, PhD
Phone
886-972651405
Email
yyhan@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin-Yi Han, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yin-Yi Han, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Vitamin D for Critically Traumatic Patients

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