In Vivo Assessment of Silver Biomaterial Nano-Toxicity
2015年7月28日 更新者：mark munger、University of Utah
Nanotechnology is the controlled generation and manipulation of matter in dimensions less than 100 nm.
Silver has been used for its bactericidal properties.
The investigators propose to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in human volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of this solution.
研究概览
研究类型
介入性
注册 (实际的)
36
阶段
- 阶段2
- 阶段1
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
-
-
Utah
-
Salt Lake City、Utah、美国、84132
- University of Utah Hospital and Clinics
-
-
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 至 80年 (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:
- Subjects must be > 18-80 years old will be included.
Exclusion Criteria:
- Females of child-bearing potential, defined as women physically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means will be excluded unless they are using 2 barrier birth control methods (i.e., diaphragm, condom, intrauterine device, sponge or spermicide) or hormonal contraceptive method.
- Any female subject who is nursing will be excluded. Subject with has a history of heavy metal allergy (including silver) or a history of asthma or COPD or renal impairment defined by a creatinine clearance below 30 ml/min.
- Subjects with symptoms of an active upper respiratory infection at time of consent will also be excluded.
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
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：10ppm Oral Silver
Oral Dose of 10ppm
|
Silver nanoparticles at 10ppm
|
|
实验性的：32ppm Oral Silver
Oral Dose of 32ppm
|
Silver nanoparticles at 32ppm
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Sodium Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Potassium Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Chloride Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Carbon Dioxide Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Urea Nitrogen Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In CreatinineBlood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Glucose Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Alkaline Phosphatase Blood Level
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Aspartate Aminotransferase Blood Level
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Alanine Aminotransferase Blood Level
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Total Protein Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Total Bilirubin Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Albumin Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Calcium Blood Level
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In White Blood Count Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Red Blood Count Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Hemoglobin Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Hematocrit Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Mean Corpuscular Volume Blood Levels
大体时间：14 days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 days
|
|
Change In Mean Corpuscular Hemoglobin Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
大体时间：14 days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 days
|
|
Change In Platelet Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Granulocytes Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Lymphocytes Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Monocytes Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Basophils Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Eosinophil Blood Levels
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Sputum Reactive Oxygen Species Change
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change to Interleukin-8 Receptor
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change to Interleukin-1 Alpha Receptor
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change to Interleukin-1 Beta Receptor
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Monocyte Chemotactic Protein 1
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Quinone Oxidoreductase 1 Gene
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change Systolic Blood Pressure
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Mean Change in Diastolic Blood Pressure
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Mean Change in Heart Rate
大体时间：14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
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：Mark A Munger, Pharm.D>、University of Utah
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
2010年12月1日
初级完成 (实际的)
2011年7月1日
研究完成 (实际的)
2011年7月1日
研究注册日期
首次提交
2010年11月16日
首先提交符合 QC 标准的
2010年11月17日
首次发布 (估计)
2010年11月18日
研究记录更新
最后更新发布 (估计)
2015年8月25日
上次提交的符合 QC 标准的更新
2015年7月28日
最后验证
2015年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 40281
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.