Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT05449522

Vitamin D for Critically Traumatic Patients

Led by National Taiwan University Hospital · Updated on 2024-08-16

100

Participants Needed

1

Research Sites

426 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Vitamin D for Critically Traumatic Patients

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 20 years old with major trauma
  • Injury Severity Score of 9 or higher
  • Admitted to the Intensive Care Unit (ICU)
Not Eligible

You will not qualify if you...

  • Chronic liver disease
  • Unable to receive enteral feeding
  • Hypercalcemia
  • Currently using vitamin D, estrogen, or bone disease medications
  • High risk of hypercalcemia from conditions like metastatic cancer, primary hyperparathyroidism, sarcoidosis, or multiple myeloma

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

Y

Yin-Yi Han, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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