Vitamin D for Critically Traumatic Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Major trauma adult (> 20 years old) with Injury Severity Score equal or higher than 9, who is admitted to ICU

Disqualifiers

Chronic liver disease

Contraindication to enteral feeds

Hypercalcemia

Current use of vitamin D, estrogen, or medications for bone disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Mortality in ICU

Time frame
up to 3 months after discharge

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.