In Vivo Assessment of Silver Biomaterial Nano-Toxicity
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in Potassium Blood Levels
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
10ppm Oral Silver
Oral Dose of 10ppm
Intervention: 10ppm Oral Silver Particle (Drug)
32ppm Oral Silver
Oral Dose of 32ppm
Intervention: 32ppm Oral Silver Particle (Drug)
Outcomes
Primary Outcomes
Change in Potassium Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Glucose Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Red Blood Count Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Sodium Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Chloride Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Alanine Aminotransferase Blood Level
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Carbon Dioxide Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Urea Nitrogen Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In CreatinineBlood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Aspartate Aminotransferase Blood Level
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Total Bilirubin Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Calcium Blood Level
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Hemoglobin Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Mean Corpuscular Volume Blood Levels
Time Frame: 14 days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Mean Corpuscular Hemoglobin Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Platelet Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Basophils Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Eosinophil Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change to Interleukin-1 Alpha Receptor
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Monocyte Chemotactic Protein 1
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Quinone Oxidoreductase 1 Gene
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Alkaline Phosphatase Blood Level
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Total Protein Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Albumin Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In White Blood Count Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Monocytes Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change to Interleukin-1 Beta Receptor
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Granulocytes Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Lymphocytes Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change to Interleukin-8 Receptor
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Hematocrit Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
Time Frame: 14 days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Sputum Reactive Oxygen Species Change
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Secondary Outcomes
- Mean Change in Diastolic Blood Pressure(14 Days)
- Change Systolic Blood Pressure(14 Days)
- Mean Change in Heart Rate(14 Days)
Investigators
mark munger
Professor
University of Utah