early vitamin d3 supplementation for critically ill patients

Conditions: Vitamin D Deficiency; Critical Illness

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.

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.

Keywords: vitamin d calcidiol levels critically ill