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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10ppm Oral Silver | Experimental | Oral Dose of 10ppm |
|
| 32ppm Oral Silver | Experimental | Oral Dose of 32ppm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10ppm Oral Silver Particle | Drug | Silver nanoparticles at 10ppm |
| |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Munger, Pharm.D> | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Hospital and Clinics | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23811290 | Derived | Munger MA, Radwanski P, Hadlock GC, Stoddard G, Shaaban A, Falconer J, Grainger DW, Deering-Rice CE. In vivo human time-exposure study of orally dosed commercial silver nanoparticles. Nanomedicine. 2014 Jan;10(1):1-9. doi: 10.1016/j.nano.2013.06.010. Epub 2013 Jun 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Study had two dosing phases. All study participants were assigned the 10ppm Oral Silver and proceed to the 32 pm Oral Silver. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 10ppm Oral Silver (3 Days) |
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| 10ppm Oral Silver (7 Days) |
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| 10ppm Oral Silver (14 Days) |
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| Washout (3 Days) |
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| 32ppm Oral Silver (14 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | 10 ppm Silver, then 32 ppm Silver |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change Systolic Blood Pressure | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mmhg | 14 Days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10ppm Oral Solution | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Munger, Pharm.D. | University of Utah | 8015816165 | mmunger@hsc.utah.edu |
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| 32ppm Oral Silver Particle |
| Drug |
Silver nanoparticles at 32ppm |
|
| 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 |
| 14 Days |
| Mean Change in Heart Rate | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 14 Days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Mean Change in Diastolic Blood Pressure | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mmhg | 14 Days |
|
|
|
| Secondary | Mean Change in Heart Rate | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | bpm | 14 Days |
|
|
|
| Primary | Change in Sodium Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mmol/L | 14 Days |
|
|
|
| Primary | Change in Potassium Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mmol/L | 14 Days |
|
|
|
| Primary | Change in Chloride Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mmol/L | 14 Days |
|
|
|
| Primary | Change in Carbon Dioxide Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mmol/L | 14 Days |
|
|
|
| Primary | Change in Urea Nitrogen Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mg/dL | 14 Days |
|
|
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| Primary | Change In CreatinineBlood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mg/dL | 14 Days |
|
|
|
| Primary | Change In Glucose Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mg/dL | 14 Days |
|
|
|
| Primary | Change In Alkaline Phosphatase Blood Level | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | u/L | 14 Days |
|
|
|
| Primary | Change In Aspartate Aminotransferase Blood Level | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | u/L | 14 Days |
|
|
|
| Primary | Change In Alanine Aminotransferase Blood Level | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | u/L | 14 Days |
|
|
|
| Primary | Change In Total Protein Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | g/dL | 14 Days |
|
|
|
| Primary | Change In Total Bilirubin Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mg/dL | 14 Days |
|
|
|
| Primary | Change in Albumin Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | g/dL | 14 Days |
|
|
|
| Primary | Change In Calcium Blood Level | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | mg/dL | 14 Days |
|
|
|
| Primary | Change In White Blood Count Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | k/uL | 14 Days |
|
|
|
| Primary | Change In Red Blood Count Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | m/uL | 14 Days |
|
|
|
| Primary | Change In Hemoglobin Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | gm/dL | 14 Days |
|
|
|
| Primary | Change In Hematocrit Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | percent | 14 Days |
|
|
|
| Primary | Change In Mean Corpuscular Volume Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | fL | 14 days |
|
|
|
| Primary | Change In Mean Corpuscular Hemoglobin Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | pg | 14 Days |
|
|
|
| Primary | Change In Mean Corpuscular Hemoglobin Concentration Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | gm/dL | 14 days |
|
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|
| Primary | Change In Platelet Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | k/uL | 14 Days |
|
|
|
| Primary | Change In Granulocytes Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | percent | 14 Days |
|
|
|
| Primary | Change In Lymphocytes Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | percent | 14 Days |
|
|
|
| Primary | Change In Monocytes Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | percent | 14 Days |
|
|
|
| Primary | Change in Basophils Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | percent | 14 Days |
|
|
|
| Primary | Change in Eosinophil Blood Levels | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | percent | 14 Days |
|
|
|
| Primary | Sputum Reactive Oxygen Species Change | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | uM | 14 Days |
|
|
|
| Primary | Change to Interleukin-8 Receptor | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | ng/mL | 14 Days |
|
|
|
| Primary | Change to Interleukin-1 Alpha Receptor | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | ng/mL | 14 Days |
|
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|
| Primary | Change to Interleukin-1 Beta Receptor | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | ng/mL | 14 Days |
|
|
|
| Primary | Change in Monocyte Chemotactic Protein 1 | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | ng/mL | 14 Days |
|
|
|
| Primary | Change in Quinone Oxidoreductase 1 Gene | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | Posted | Mean | 95% Confidence Interval | ng/mL | 14 Days |
|
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|
| 1 |
| 36 |
| 0 |
| 36 |
| EG001 | 32ppm Oral Solution | All participants received the 10ppm Silver, then progressed to the 32 ppm Silver. | 0 | 24 | 0 | 24 |
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