- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03639584
Prevalence of Deficiency of Vitamin D in Critically Ill Patients
Investigating the Prevalence of Deficiency of Vitamin D in Critically Ill Patients and Its Effects on the Prognosis
연구 개요
상세 설명
Studies have revealed that the serum level of 25-hydroxyvitamin D, as known as calcidiol, is low in critically ill patients. The prevalence ranges from 26 to 82%. 25-hydroxyvitamin D deficiency is associated with longer ICU stay, higher medical cost and higher death rate in septic patients. 25-hydroxyvitamin D is a kind of hormone related to bone and mineral metabolism. Moreover, the receptors were found in almost all cells, and it is related to immune system, cytokine release, cellular proliferation and differentiation, angiogenesis, and muscular energy. The main source is skin metabolism triggered by sunshine and food consumption. It is subsequently converted to calcifediol in the liver and then calcitriol in the kidney (the active form). Its serum level is regulated by parathyroid hormone and serum calcium and phosphate. The critically ill patients are deprived of sunshine, suffered from poor nutrition support, impaired liver and kidney function, higher rate of consumption, and are under higher risk of deficiency. Nowadays, the studies about 25-hydroxyvitamin D in ICU patients were conducted mostly in Europe and America. There is no large-scale study in Taiwan or Asia. A randomized controlled study from Austria has shown large dose supply in patients with 25-hydroxyvitamin D deficiency could decrease the mortality.
The object of this multi-center study is to investigate the prevalence of 25-hydroxyvitamin D deficiency, the risk factors and the correlation with outcomes. The results could be a step-stone for future randomized controlled studies.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Taipei, 대만, 100
- National Taiwan University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- All ICU patients
Exclusion Criteria:
- 1, Less than 20 years 2, BMI < 18 kg/m^2 3, Had large dose vit D within previous four weeks (over 3000 IU per day) 4, ICU admission within previous three months 5, Have disease affecting vit D level, calcium metabolism, bone metabolism such as parathyroid disease, Rickets, liver cirrhosis child C 6, Communication difficulty
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Group 1
Patients admitted to ICU less than 48 hours and the anticipated stay is less than 5 days.
Take blood sample on the day of enrollment.
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Group 2
Patients admitted to ICU less than 48 hours and the anticipated stay is longer than 5 days.
Take blood sample on the day of enrollment, 7th, 14th, 21st, and 28th.
Stop blood sample once exit.
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Group 3
Patients admitted to ICU 3~7 days.
Take blood sample on the day of enrollment.
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Group 4
Patients admitted to ICU 8~14 days.
Take blood sample on the day of enrollment.
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Group 5
Patients admitted to ICU 15~28 days.
Take blood sample on the day of enrollment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The prevalence of Vitamin D deficiency
기간: 1 day at enrollment
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Investigate the prevalence of vitamin D deficiency among groups
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1 day at enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Difference of mortality on 28th and 90th day in group 2
기간: 90 days
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Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 2
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90 days
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Difference of mortality on 28th and 90th day in group 3, 4, and 5
기간: 90 days
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Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 3, 4, and 5
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90 days
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Serial changes of serum vitamin D levels in group 2
기간: 28 days
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investigate the serum vitamin D levels at different time points in group 2
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28 days
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Difference of 28-day ventialtor-free days
기간: 28 days
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Compare the 28-day ventialtor-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups
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28 days
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Difference of 28-day ICU-free days
기간: 28 days
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Compare the 28-day ICU-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups
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28 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Chung-Wei Chen, MD, Far Eastern Memorial Hospital
- 수석 연구원: Li-Kuo Kuo, MD, Mackay Memorial Hospital
- 수석 연구원: Kuo-Ching Yuan, MD, Taipei Medical University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .