Critical Illness, Vitamin D Deficiency
Conditions
Keywords
vitamin D, calcidiol levels, critically ill
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.
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
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality rate | 30 days | 30-day mortality rate after intervention with the study samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality rate of patients who survives >7 days | 30 days | 30-day mortality rate of patients who survives \>7 days after intervention with the study. samples |
| Length of ICU stay for surviving patients | 30 days | Length of ICU stay for surviving patients. |
| 30-day mortality based on serum 25(OH)D levels on day 7 | 30 days | 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. |
| Length of hospital stay for surviving patients | 30 days | Length of hospital stay for surviving patients. |
| 30-day mortality based on APACHE II scores at ICU 24 hours | 30 days | Comparison of 30-day mortality between the three groups based on 24-hour APACHE II scores: \<20, 20-39, and ≥39. |
| Correlation of 25(OH)D increment after vitamin D supplement and body weight | 7 days | Correlation between 25(OH)D levels and body weight on day 7 after supplementation in the treatment group. |
| 30-day mortality based on serum 25(OH)D levels on day 30 | 30 days | Comparison of 30-day mortality between the two treatment groups based on serum 25(OH)D levels on day 30: ≥ 30 ng/mL vs. \< 30 ng/mL. |
Countries
Taiwan
Contacts
Primary ContactYin Yi Han, doctor
Outcome results
None listed