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临床试验/NCT05937789
NCT05937789招募中不适用

Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年1月22日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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