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Early Vitamin D3 Supplementation for Critically Ill Patients

RecruitingNAAges 18 Years - anyAllNational Taiwan University Hospital
NCT05937789 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vitamin D3
  • Medium Chain Triglycerides (MCT)
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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