Acute Effect of Systemic Stress on Measured Blood Concentrations of 25 (OH) Vitamin D (ASSESS-D)
2021年4月1日 更新者：Intermountain Health Care, Inc.
Each patient who is admitted for preoperative preparation for elective open heart surgery at Intermountain Medical Center will be invited to participate in this study.
After a written informed consent is obtained, patients meeting inclusion/exclusion criteria will be randomized 1:1 to the treatment arm or placebo/control arm.
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.
The first dose will be given the evening before surgery.
The second and third doses will be given either orally or per NG tube on the mornings of post-op days 1 and 2. Blood will be obtained at the following time periods: 1) At baseline pre-procedure 12 to 18 hours before planned surgery; 2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4) 72 hours after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and 6) At the 6-month follow-up visit (post-surgery).
Plasma levels of 25(OH) vitamin D will be measured on each sample.
研究概览
详细说明
Each patient who is admitted for preoperative preparation for elective open heart surgery at Intermountain Medical Center will be invited to participate in this study.
The patient's history and medical records will be reviewed and data gathered will be used to evaluate the patient's relationship to inclusion and exclusion criteria.
After a written informed consent is obtained, subjects will be randomized 1:1 to the treatment arm or placebo/control arm.
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.
The first dose will be given the evening before surgery.
The second and third doses will be given either orally or per NG tube on the mornings of post-op days 1 and 2. Approximately 15-20 ml (about one tablespoon) of blood will be obtained at the following time periods (+/- 4 hours): 1) At baseline pre-procedure 12 to 18 hours before planned surgery; 2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4) 72 hours after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and 6) At the 6-month follow-up visit (post-surgery).
Each blood sample will be transported to The Center for Molecular and Genetic Research at LDS Hospital Cardiovascular Genetics Laboratory for preparation and storage.
Plasma levels of 25(OH) vitamin D will be measured on each sample.
研究类型
介入性
注册 (实际的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Utah
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Murray、Utah、美国、84143
- Intermountain Heart Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female >= 18 years of age
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
- Subject is scheduled for elective open heart surgery at Intermountain Medical Center
- Subject is relatively stable as assessed by the Principal Investigator
Exclusion Criteria:
- Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
- History of previous vitamin D supplementation > 1,000 units of vitamin D3 per day within the past three months.
- Evidence of hypercalcemia on screening labs (> 10.5 milligrams per deciliter of blood).
- Any scheduled cardiac surgical procedure that does not require open thoracotomy (the reason for this exclusion is that the study design requires that the patients will undergo a significantly stressful procedure, which can be generally guaranteed if the patient undergoes open thoracotomy).
- Known allergic reaction or other intolerance to oral vitamin D3.
- Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Principal Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- Subject participation in previous investigational interventional studies within 30 days of the current study.
- Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Treatment
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.
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Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation.
The first dose will be given the evening before surgery.
The second and third doses will be given either orally or per NG tube on days 1 and 2 after surgery.
|
|
安慰剂比较：Placebo/Control Arm
Those randomized to the control arm will receive three oral placebo doses.
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Those randomized to the control arm will receive three placebo doses.
The first dose will be given the evening before surgery.
The second and third doses will be given either orally or per NG tube on days 1 and 2 after surgery.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Changes in 25(OH) vitamin D levels (ng/ml) between baseline (pre-surgery) and 72 hours post-surgery.
大体时间：72 hours
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72 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Comparison of 25(OH) vitamin D levels (ng/ml) between baseline and other time points.
大体时间：12-24 hrs, 48 hrs, discharge (approximately 5-8 days post-surgery), 6 months
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Subjects will be re-assessed on post-operative day 1 (12-24 hours after surgery), then at 48 and 72 hours post-surgery, at discharge (approximately 5-8 days post-surgery), and at a 6 month post-surgery follow-up visit.
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12-24 hrs, 48 hrs, discharge (approximately 5-8 days post-surgery), 6 months
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Percent differences in adverse clinical outcomes between the vitamin D3 supplementation treatment and placebo arms.
大体时间：6 months
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Clinical outcomes that will be monitored include: death, myocardial infarction, stroke, repeat coronary revascularization or hospitalization for heart failure, worsening of renal function, hospitalization for pneumonia or other acute systemic infection or any other serious adverse clinical event.
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6 months
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Time to adverse clinical events stratified by vitamin D3 supplementation and placebo arms.
大体时间：6 months
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Clinical outcomes that will be monitored include: death, myocardial infarction, stroke, repeat coronary revascularization or hospitalization for heart failure, worsening of renal function, hospitalization for pneumonia or other acute systemic infection or any other serious adverse clinical event.
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Joseph B Muhlestein, MD、Intermountain Health Care, Inc.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年7月1日
初级完成 (实际的)
2018年10月1日
研究完成 (实际的)
2020年10月1日
研究注册日期
首次提交
2015年4月8日
首先提交符合 QC 标准的
2015年5月29日
首次发布 (估计)
2015年6月2日
研究记录更新
最后更新发布 (实际的)
2021年4月5日
上次提交的符合 QC 标准的更新
2021年4月1日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Vitamin D3的临床试验
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Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, Denmark完全的
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Riphah International University招聘中