Early Vitamin D3 Supplementation for Critically Ill Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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

Qualifiers

≥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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vitamin D3
  • Medium Chain Triglycerides (MCT)

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.