Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- 30-day mortality rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
结局指标
主要结局
30-day mortality rate
时间窗: 30 days
30-day mortality rate after intervention with the study samples.
次要结局
- 30-day mortality rate of patients who survives >7 days(30 days)
- 30-day mortality based on APACHE II scores at ICU 24 hours(30 days)
- 30-day mortality based on serum 25(OH)D levels on day 7(30 days)
- 30-day mortality based on serum 25(OH)D levels on day 30(30 days)
- Length of ICU stay for surviving patients(30 days)
- Length of hospital stay for surviving patients(30 days)
- Correlation of 25(OH)D increment after vitamin D supplement and body weight(7 days)
