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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

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

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Yin-Yi Han, MD, PhD
yyhan@ntuh.gov.tw
886-972651405
Time Frame
Start Date: 2018-05-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 100
Treatments
Experimental: Treatment group
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.
Placebo_comparator: Control group
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov