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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05449522
Other study ID # 201705002MIPC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date July 1, 2026

Study information

Verified date March 2024
Source National Taiwan University Hospital
Contact Yin-Yi Han, MD, PhD
Phone 886-972651405
Email yyhan@ntuh.gov.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Major trauma adult (> 20 years old) with Injury Severity Score equal or higher than 9, 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vitamin D
High dose of vitamin D with 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) is given orally or enterally via a feeding tube
Placebo
Medium-chain triglyceride (MCT)

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Mortality in ICU up to 3 months after discharge
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