In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Study Overview
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Brief Summary
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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.

Official Title
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In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Conditions
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Healthy

Intervention / Treatment
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* Drug: 10ppm Oral Silver Particle
* Drug: 32ppm Oral Silver Particle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10ppm Oral Silver<br>Oral Dose of 10ppm | Drug: 10ppm Oral Silver Particle<br>* Silver nanoparticles at 10ppm<br>|
| Experimental: 32ppm Oral Silver<br>Oral Dose of 32ppm | Drug: 32ppm Oral Silver Particle<br>* Silver nanoparticles at 32ppm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sodium Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change in Potassium Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change in Chloride Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change in Carbon Dioxide Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change in Urea Nitrogen Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In CreatinineBlood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Glucose Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Alkaline Phosphatase Blood Level | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Aspartate Aminotransferase Blood Level | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Alanine Aminotransferase Blood Level | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Total Protein Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Total Bilirubin Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change in Albumin Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Calcium Blood Level | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In White Blood Count Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Red Blood Count Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Hemoglobin Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Hematocrit Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Mean Corpuscular Volume Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 days | 
| Change In Mean Corpuscular Hemoglobin Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Mean Corpuscular Hemoglobin Concentration Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 days | 
| Change In Platelet Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Granulocytes Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Lymphocytes Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change In Monocytes Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change in Basophils Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change in Eosinophil Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Sputum Reactive Oxygen Species Change | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change to Interleukin-8 Receptor | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change to Interleukin-1 Alpha Receptor | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change to Interleukin-1 Beta Receptor | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change in Monocyte Chemotactic Protein 1 | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Change in Quinone Oxidoreductase 1 Gene | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Systolic Blood Pressure | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Mean Change in Diastolic Blood Pressure | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days | 
| Mean Change in Heart Rate | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days |