Vitamin D for Critically Traumatic Patients

NCT05449522 | Recruiting

• 1 other identifier: 201705002MIPC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Major Trauma

Keywords

Vitamin D; Major Trauma

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality in ICU

  up to 3 months after discharge

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Treatment group

Placebo DIETARY_SUPPLEMENT

Medium-chain triglyceride (MCT)

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yin-Yi Han, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yin-Yi Han, MD, PhD

CONTACT

886-972651405; yyhan@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 8, 2022
• Study Start: May 1, 2018
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

TW (1)