Early Vitamin D3 Supplementation for Critically Ill Patients
Recruiting now · Not applicable
Conditions studied: Vitamin D Deficiency, Critical Illness
In brief
There are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. 240 patients with low calcidiol levels will be enrolled and be provided varying supplementation doses to maintain their serum calcidiol levels ≥ 30 ng/mL within 30 days of ICU admission. The serum levels of calcidiol and PTH will be measured on Day 0, Day 7, Day 14 and Day 30 before and after vitamin D supplementation. The results will serve as a valuable reference for intensivists when formulating appropriate vitamin D treatment strategy to maximize clinical benefits for critically ill patients.
Key facts
- Study ID
- NCT05937789
- Run by
- National Taiwan University Hospital
- People needed
- 240
- Starts
- 2024-01-22
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-08-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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.
You may not qualify if…
- 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 it is running
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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