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Early Vitamin D3 Supplementation for Critically Ill Patients

ConditionsVitamin D DeficiencyCritical Illness
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Vitamin D3

    Dietary supplement

    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)

    Dietary supplement

    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

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Control1Placebo comparator 1 intervention
Group B: Control2Placebo comparator 1 intervention
Group C: Control3Placebo comparator 1 intervention
Group D: Vitamin D1Experimental treatment 1 intervention
Group E: Vitamin D2Experimental treatment 1 intervention
Group F: Vitamin D3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

30-day mortality rate

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

Time frame
30 days

Secondary outcomes

1

30-day mortality rate of patients who survives >7 days

30-day mortality rate of patients who survives \>7 days after intervention with the study. samples

Time frame
30 days
2

Length of ICU stay for surviving patients

Length of ICU stay for surviving patients.

Time frame
30 days
3

Length of hospital stay for surviving patients

Length of hospital stay for surviving patients.

Time frame
30 days
4

30-day mortality based on serum 25(OH)D levels on day 7

Comparison of 30-day mortality between the two treatment groups based on serum 25(OH)D levels on day 7: ≥ 30 ng/mL vs. \< 30 ng/mL.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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