Ireland
--:--IST
Recruiting Not applicable

Early Vitamin D3 Supplementation for Critically Ill Patients

NCT05937789 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2024-01-22
Last updated
2024-08-16

Condition(s) studied

Vitamin D DeficiencyCritical Illness

Investigational drug(s) / intervention(s)

Vitamin D3Medium Chain Triglycerides (MCT)

Vitamin D3: Dose of vitamin D3 depends on participant's serum 25(OH)D levels, with one sample bottle contains 72,000 IU of vitamin D3; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours

Medium Chain Triglycerides (MCT): Dose of MCT depends on participant's serum 25(OH)D levels, with one sample bottle contains 5 cc. of MCT; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 30-day mortality rate — 30 days
    30-day mortality rate after intervention with the study samples.

Trial sites (1)

FacilityCityRegionStatus
National Taiwan University Hospital Taipei Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05937789 on ClinicalTrials.gov ↗ ← All trials in Taiwan