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The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 32ppm Oral Silver | Experimental | 14 Days Active Silver Solution |
|
| Sterile Water | Placebo Comparator | No Silver Nanoparticles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 32ppm Silver Particle | Drug | Oral silver dose of 32ppm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change Sodium Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change Potassium Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 days |
| Change in Chloride Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 days |
| Change in Carbon Dioxide Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 days |
| Change In Urea Nitrogen Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 days |
| Change In Creatinine Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Glucose Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Alkaline Phosphatase Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) |
| Measure | Description | Time Frame |
|---|---|---|
| Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Munger, Pharm.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112-5820 | 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 | All participants were dosed with the placebo (14 days), then they all had a 72hr washout period. Last all participants were dosed with the 32ppm Oral Silver for (14 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Dose Placebo (14 Days) |
| |||||||||||||
| 72 hr Washout |
| |||||||||||||
| Second Dose 32ppm Oral Silver (14 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| 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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change Sodium Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | mmol/L | 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 | ASAP 32 Ppm Solution Experimental |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pulmonary embolism at 12 days of placebo diluent. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Munger | University of Utah | 801-581-6165 | mmunger@hsc.utah.edu |
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| Placebo |
| Drug |
Sterile Water No Silver |
|
| 14 Days |
| Change In Aspartate Aminotransferase Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Alanine Aminotransferase Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change in Total Protein Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Total Bilirubin Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Albumin Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Calcium Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In White Blood Count Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Red Blood Count Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Hemoglobin Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Hematocrit Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Mean Corpuscular Volume Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Mean Corpuscular Hemoglobin Concentration Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Platelet Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Granulocytes Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Lymphocytes Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Monocytes Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Basophils Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Change In Eosinophils Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | 14 Days |
| Cytochrome P450 Assay on Dextromethorphan in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days |
| Cytochrome P450 Assay on Losartan in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days |
| Cytochrome P450 Assay on Caffeine in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days |
| Cytochrome P450 Assay on Omeprazole in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days |
| Cytochrome P450 Assay on Midazolam in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | 14 Days |
| Total Change in Systolic Blood Pressure Silver Participants | Assessment only completed on the 32ppm Oral Silver part of the trail | Baseline and 14 Days |
| Total Change in Diastolic Blood Pressure Silver Participants | Assessment only completed on the 32ppm Oral Silver part of the trail | Baseline and 14 Days |
| Total Change in Heart Rate in Silver Participants | Assessment only completed on the 32ppm Oral Silver part of the trail | Baseline and 14 Days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Change Potassium Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | mmol/L | 14 days |
|
|
|
| Primary | Change in Chloride Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | mmol/L | 14 days |
|
|
|
| Primary | Change in Carbon Dioxide Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | mmol/L | 14 days |
|
|
|
| Primary | Change In Urea Nitrogen Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | mg/dL | 14 days |
|
|
|
| Primary | Change In Creatinine Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | mg/dL | 14 Days |
|
|
|
| Primary | Change In Glucose Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | mg/dl | 14 Days |
|
|
|
| Primary | Change In Alkaline Phosphatase Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | U/L | 14 Days |
|
|
|
| Primary | Change In Aspartate Aminotransferase Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | U/L | 14 Days |
|
|
|
| Primary | Change In Alanine Aminotransferase Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | U/L | 14 Days |
|
|
|
| Primary | Change in Total Protein Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | g/dL | 14 Days |
|
|
|
| Primary | Change In Total Bilirubin Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | mg/dL | 14 Days |
|
|
|
| Primary | Change In Albumin Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | g/dL | 14 Days |
|
|
|
| Primary | Change In Calcium Blood Level | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | mg/dL | 14 Days |
|
|
|
| Primary | Change In White Blood Count Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | k/uL | 14 Days |
|
|
|
| Primary | Change In Red Blood Count Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | M/uL | 14 Days |
|
|
|
| Primary | Change In Hemoglobin Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | gm/dL | 14 Days |
|
|
|
| Primary | Change In Hematocrit Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | percent | 14 Days |
|
|
|
| Primary | Change In Mean Corpuscular Volume Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | fL | 14 Days |
|
|
|
| Primary | Change In Mean Corpuscular Hemoglobin Concentration Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | gm/dL | 14 Days |
|
|
|
| Primary | Change In Platelet Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | k/uL | 14 Days |
|
|
|
| Primary | Change In Granulocytes Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | percent | 14 Days |
|
|
|
| Primary | Change In Lymphocytes Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | percent | 14 Days |
|
|
|
| Primary | Change In Monocytes Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | percent | 14 Days |
|
|
|
| Primary | Change In Basophils Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | percent | 14 Days |
|
|
|
| Primary | Change In Eosinophils Blood Levels | Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm) | Posted | Mean | Standard Deviation | percent | 14 Days |
|
|
|
| Primary | Cytochrome P450 Assay on Dextromethorphan in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | Posted | Mean | Standard Deviation | ng/ml | 14 Days |
|
|
|
| Primary | Cytochrome P450 Assay on Losartan in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | Posted | Mean | Standard Deviation | ng/ml | 14 Days |
|
|
|
| Primary | Cytochrome P450 Assay on Caffeine in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | Posted | Mean | Standard Deviation | ng/ml | 14 Days |
|
|
|
| Primary | Cytochrome P450 Assay on Omeprazole in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | Posted | Mean | Standard Deviation | ng/ml | 14 Days |
|
|
|
| Secondary | Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | Posted | Mean | Standard Deviation | ng/ml | 14 Days |
|
|
|
| Primary | Cytochrome P450 Assay on Midazolam in Participants | Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm. | Posted | Mean | Standard Deviation | ng/ml | 14 Days |
|
|
|
| Secondary | Total Change in Systolic Blood Pressure Silver Participants | Assessment only completed on the 32ppm Oral Silver part of the trail | Posted | Mean | 95% Confidence Interval | mmhg | Baseline and 14 Days |
|
|
|
| Secondary | Total Change in Diastolic Blood Pressure Silver Participants | Assessment only completed on the 32ppm Oral Silver part of the trail | Posted | Mean | 95% Confidence Interval | mmhg | Baseline and 14 Days |
|
|
|
| Secondary | Total Change in Heart Rate in Silver Participants | Assessment only completed on the 32ppm Oral Silver part of the trail | Posted | Mean | 95% Confidence Interval | beats per minute | Baseline and 14 Days |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Silver Biotics 32 Ppm Diluent | 1 | 12 | 0 | 12 |
|
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