High-dose vitamin D supplementation for critically injured patients
Effects of High Doses of Liquid Vitamin D Supplementation on Clinical Outcomes in Critically Traumatic Patients.
This study is testing if giving high doses of vitamin D to critically injured patients can help them recover better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05449522 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high-dose vitamin D supplementation on critically traumatic patients with an Injury Severity Score of 9 or higher. The trial aims to determine if administering multiple high doses of vitamin D within one week can reduce mortality and morbidity rates in these patients. Serum levels of calcidiol and parathyroid hormone (PTH) will be measured at specified intervals to assess the impact of the intervention. The study is conducted at the National Taiwan University Hospital, focusing on a significant public health issue related to trauma.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with major trauma and an Injury Severity Score of 9 or higher admitted to the ICU.
Not a fit: Patients with chronic liver disease, hypercalcemia, or those currently using vitamin D or related medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and clinical outcomes for critically injured patients suffering from vitamin D deficiency.
How similar studies have performed: Previous studies have indicated that vitamin D supplementation can improve outcomes in critically ill patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yin-Yi Han, MD, PhD — National Taiwan University Hospital
- Study coordinator: Yin-Yi Han, MD, PhD
- Email: yyhan@ntuh.gov.tw
- Phone: 886-972651405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.