Vitamin D for Critically Traumatic Patients

Vitamin D Deficiency Clinical Trial

Official title:

Effects of High Doses of Liquid Vitamin D Supplementation on Clinical Outcomes in Critically Traumatic Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449522
• Other study ID #: 201705002MIPC
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Major Trauma
• Vitamin D Deficiency

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