Vitamin D for Critically Traumatic Patients

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05449522
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 71
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency; Major Trauma	Other: Vitamin D; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of High Doses of Liquid Vitamin D Supplementation on Clinical Outcomes in Critically Traumatic Patients.
• Actual Study Start Date: May 1, 2018
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group	Other: Vitamin D; High dose of vitamin D is given in divided dose orally or enterally via a feeding tube
Placebo Comparator: Control group	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Mortality [up to 3 months after discharge]

   Mortality in ICU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Major trauma adult (> 20 years old) with Injury Severity Score equal or higher than 16, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Yin-Yi Han, MD, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05449522
• Other Study ID Numbers: 201705002MIPC
• First Posted: Jul 8, 2022
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital: Vitamin D; Major Trauma
• Additional relevant MeSH terms: Vitamin D Deficiency; Vitamin D

Study Results

No Results Posted as of Jul 8, 2022