Early Vitamin D3 Supplementation for Critically Ill Patients

National Taiwan University

Status: Enrolling

Conditions: Vitamin D Deficiency; Critical Illness

Treatments: Dietary Supplement: Medium Chain Triglycerides (MCT); Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT05937789

202305074RIPC

Details and patient eligibility

About

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.

Full description

Recent studies have highlighted a prevalent vitamin D deficiency in critically ill patients, ranging from 26% to 82%. These patients experience longer ICU stays, higher medical expenses, and increased sepsis-related mortality. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. In the first phase, the epidemiological investigation found significantly lower serum calcidiol levels of approximately 20.9 ng/mL compared to the normal range of 30-60 ng/mL in ICU patients. The second phase, a randomized control study, preliminarily demonstrated that supplementing 576,000 IU of vitamin D3 in critically ill patients with serum calcidiol levels below 20 ng/mL significantly reduced the risk of multidrug resistant bacterial infections within 30 days. An Austrian trial also showed that adequate vitamin D supplementation lowered in-hospital mortality in severely deficient patients. The importance of vitamin D supplementation for critically ill patients with vitamin D deficiency is evident, as their clinical prognosis is closely related to achieving adequate serum calcidiol levels. However, 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 will enroll 240 patients with low calcidiol levels and provide 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

240 participants in 6 patient groups, including a placebo group

Control1

Placebo Comparator group

Description:

Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving 40 cc. medium-chain triglyceride (MCT) supplement.

Treatment:

Dietary Supplement: Medium Chain Triglycerides (MCT)

Control2

Placebo Comparator group

Description:

Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving 50 cc. MCT supplement.

Treatment:

Dietary Supplement: Medium Chain Triglycerides (MCT)

Control3

Placebo Comparator group

Description:

Participants with serum 25(OH)D levels below 12 ng/mL, receiving 60 cc. MCT supplement.

Treatment:

Dietary Supplement: Medium Chain Triglycerides (MCT)

Vitamin D1

Experimental group

Description:

Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving vitamin D3 of 576,000 IU supplement

Treatment:

Dietary Supplement: Vitamin D3

Vitamin D2

Experimental group

Description:

Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving vitamin D3 of 720,000 IU supplement

Treatment:

Dietary Supplement: Vitamin D3

Vitamin D3

Experimental group

Description:

Participants with serum 25(OH)D levels below 12 ng/mL, receiving vitamin D3 of 864,000 IU supplement

Treatment:

Dietary Supplement: Vitamin D3