Early vitamin D3 supplementation for critically ill patients

Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients

This study tests if giving vitamin D3 early to critically ill patients with low levels can improve their health while they are in the ICU.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT05937789 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of early vitamin D3 supplementation on critically ill patients with low calcidiol levels. Conducted in Taiwan, it aims to enroll 240 patients who will receive varying doses of vitamin D to maintain serum calcidiol levels above 30 ng/mL within 30 days of ICU admission. The study measures serum calcidiol and PTH levels at multiple time points to assess the impact of supplementation on patient outcomes. The findings will help establish guidelines for vitamin D treatment in critically ill patients.

Who should consider this trial

Good fit: Ideal candidates are critically ill patients aged 18 and older with serum 25(OH)D levels below 20 ng/mL and expected ICU stays of at least 72 hours.

Not a fit: Patients with conditions affecting calcium metabolism, recent high-dose vitamin D therapy, or active COVID-19 will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve clinical outcomes and reduce complications for critically ill patients with vitamin D deficiency.

How similar studies have performed: Previous studies have shown that vitamin D supplementation can reduce in-hospital mortality and infection rates in severely deficient patients, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* ≥18-year-old critically ill patient.
* ICU admission \< 24 hours.
* Baseline 25(OH)D levels within 24 hours of ICU admission \< 20 ng/mL.
* Expected ICU length of stay ≥ 72 hours.

Exclusion Criteria:

* Hypercalcemia (ie. total serum calcium levels \> 2.6 mmol/L).
* Disorders affecting serum 25(OH)D levels, calcium metabolism, or bone metabolism (eg, parathyroid disease, rickets, or severe cirrhosis \[Child C\]).
* Having received high-dose vitamin D3 therapy (ie. \> 2,000 IU daily or a single dose of ≥ 10,000 IU) within the past four weeks.
* Active COVID-19 at ICU admission.
* Organ transplant.
* Having had tuberculosis, sarcoidosis or kidney stones within the past year.
* Having renal dialysis, continuous kidney replacement therapy (CKRT), acute kidney injury (AKI).
* Having ICU admission within the past three months.
* Non-native-speaking patients and their families
* Pregnant women.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Yin Yi Han, doctor

Conditions Vitamin D Deficiency; Critical Illness; vitamin D; calcidiol levels; critically ill