Early Vitamin D3 Supplementation for Critically Ill Patients

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Jun 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of early vitamin D3 supplementation in critically ill patients who have low levels of vitamin D. Researchers want to find out if giving these patients vitamin D can help improve their health during their time in the Intensive Care Unit (ICU). The study will involve 240 patients in Taiwan who have been admitted to the ICU with low vitamin D levels. These patients will receive different doses of vitamin D to see which amount helps them reach healthy vitamin D levels within 30 days of being admitted.

To participate in this trial, patients must be at least 18 years old, be critically ill, and have low vitamin D levels (less than 20 ng/mL) when they enter the ICU. They should also expect to stay in the ICU for at least three days. However, some individuals may not be eligible, such as those with certain health conditions or recent high doses of vitamin D. Throughout the study, researchers will check the patients' vitamin D levels at specific times to see how well the treatment is working. This trial aims to provide important information that doctors can use to better treat critically ill patients with vitamin D deficiency.

Gender

ALL

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.