Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05449522

Vitamin D for Critically Traumatic Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Yin-Yi Han, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

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

Dietary Supplement

Medium-chain triglyceride (MCT)

Primary outcomes

  1. Mortality

    Time frame: up to 3 months after discharge

    Mortality in ICU

Study contacts

Contact information is provided by the study sponsor or research team.

Yin-Yi Han, MD, PhD

CONTACT

[email protected]

886-972651405

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2022
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.