Vitamin D for Critically Traumatic Patients

Not Applicable

Recruiting

• Conditions: Major Trauma; Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D; Dietary Supplement: Placebo

• Registration Number: NCT05449522
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16
• Primary Completion: 2026-01-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Vitamin D	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.
Control group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mortality	up to 3 months after discharge	Mortality in ICU

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan