RecruitingNot ApplicableNCT05937789

Early Vitamin D3 Supplementation for Critically Ill Patients

Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients

Sponsor

National Taiwan University Hospital

Enrollment

240 participants

Start Date

Jan 22, 2024

Study Type

INTERVENTIONAL

Conditions

Critical Illness Vitamin D Deficiency

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

Min Age: 18 Years

Inclusion Criteria4

≥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 Criteria10

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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Interventions

DIETARY_SUPPLEMENTVitamin 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

DIETARY_SUPPLEMENTMedium 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