Vitamin D for Critically Traumatic Patients

National Taiwan University

Status: Enrolling

Conditions: Major Trauma; Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05449522

201705002MIPC

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D

Control group

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo