NCT05937789 Early Vitamin D3 Supplementation for Critically Ill Patients
| NCT ID | NCT05937789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Vitamin D Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2024-01-22 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05937789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vitamin D Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05937789 currently recruiting?
Yes, NCT05937789 is actively recruiting participants. Contact the research team at noviahan@gmail.com for enrollment information.
Where is the NCT05937789 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05937789 clinical trial?
NCT05937789 is sponsored by National Taiwan University Hospital. The trial plans to enroll 240 participants.