Clinical trial NCT05937789: Early Vitamin D3 Supplementation for Critically Ill Patients
Official title: Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vitamin D Deficiency
Critical Illness
Keywords: vitamin D
calcidiol levels
critically ill
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: 30-day mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: 30-day mortality rate of patients who survives >7 days
timeFrame: 30 days
measure: Length of ICU stay for surviving patients
timeFrame: 30 days
measure: Length of hospital stay for surviving patients
timeFrame: 30 days
measure: 30-day mortality based on serum 25(OH)D levels on day 7
timeFrame: 30 days
measure: 30-day mortality based on serum 25(OH)D levels on day 30
timeFrame: 30 days
measure: 30-day mortality based on APACHE II scores at ICU 24 hours
timeFrame: 30 days
measure: Correlation of 25(OH)D increment after vitamin D supplement and body weight
timeFrame: 7 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: