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
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Major Trauma
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
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
NCT ID
NCT05449522
First Posted
July 5, 2022
Last Updated
December 6, 2022
Sponsor
National Taiwan University Hospital
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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