In Vivo Assessment of Silver Biomaterial Nano-Toxicity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Potassium Blood Levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be > 18-80 years old will be included.
排除标准
- •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.
研究组 & 干预措施
10ppm Oral Silver
Oral Dose of 10ppm
干预措施: 10ppm Oral Silver Particle (Drug)
32ppm Oral Silver
Oral Dose of 32ppm
干预措施: 32ppm Oral Silver Particle (Drug)
结局指标
主要结局
Change in Potassium Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Glucose Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Red Blood Count Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Sodium Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Chloride Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Alanine Aminotransferase Blood Level
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Carbon Dioxide Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Urea Nitrogen Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In CreatinineBlood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Aspartate Aminotransferase Blood Level
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Total Bilirubin Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Calcium Blood Level
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Hemoglobin Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Mean Corpuscular Volume Blood Levels
时间窗: 14 days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Mean Corpuscular Hemoglobin Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Platelet Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Basophils Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Eosinophil Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change to Interleukin-1 Alpha Receptor
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Monocyte Chemotactic Protein 1
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Quinone Oxidoreductase 1 Gene
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Alkaline Phosphatase Blood Level
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Total Protein Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Albumin Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In White Blood Count Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Monocytes Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change to Interleukin-1 Beta Receptor
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Granulocytes Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Lymphocytes Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change to Interleukin-8 Receptor
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Hematocrit Blood Levels
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
时间窗: 14 days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Sputum Reactive Oxygen Species Change
时间窗: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
次要结局
- Mean Change in Diastolic Blood Pressure(14 Days)
- Change Systolic Blood Pressure(14 Days)
- Mean Change in Heart Rate(14 Days)