An interventional study of Vitamin D and Placebo in Vitamin D Deficiency and Major Trauma, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
773 studies on the registry are indexed under Vitamin D Deficiency; 62 are open to participants now.
This study's planned enrollment of 100 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 568 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with the following conditions:
Experimental group will receive 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) theoretically to achieve sufficient level of vitamin D.
Dietary Supplement: Vitamin D
Dietary Supplement: Placebo
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
Medium-chain triglyceride (MCT)
Mortality
Mortality in ICU
Time frame: up to 3 months after discharge
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National Taiwan University Hospital