Vitamin D for Critically Traumatic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin D, Placebo.
- Who it may be relevant to
- Registry conditions: Vitamin D Deficiency, Major Trauma. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of High Doses of Liquid Vitamin D Supplementation on Clinical Outcomes in Critically Traumatic Patients.
Overview
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.
Interventions
- Dietary supplement Vitamin D
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 - Dietary supplement Placebo
Medium-chain triglyceride (MCT)
Primary outcome measures
- Mortality [Time frame: up to 3 months after discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT05449522 · 201705002MIPC