Vitamin D for Critically Traumatic Patients

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05449522

Enrollment

100

Registered

2022-07-08

Start date

2018-05-01

Completion date

2026-07-01

Last updated

2024-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Trauma, Vitamin D Deficiency

Keywords

Vitamin D, Major Trauma

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. The serum levels of calcidiol and PTH will be measured on Day 0, Day 3, Day 10, Day 15, Day 30 and Day 60 before and after vitamin D supplementation.

Interventions

DIETARY_SUPPLEMENTVitamin 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

DIETARY_SUPPLEMENTPlacebo

Medium-chain triglyceride (MCT)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality	up to 3 months after discharge	Mortality in ICU

Countries

Taiwan

Contacts

Primary ContactYin-Yi Han, MD, PhD

yyhan@ntuh.gov.tw886-972651405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026