University of Utah
Salt Lake City, Utah, 84112-5820, United States
Completed
NCT Number: NCT01405794
In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm
The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.
Completed
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 18-80 years old without debilitating chronic disease or history of cardiovascular event.
Exclusion criteria
- Women physically capable of becoming pregnant, who are not using 2 barrier methods of birth control;
- Any female who is nursing;
- History of heavy metal allergy;
- History of asthma or Chronic Obstructive Pulmonary Disease;
- History of renal impairment;
- Symptoms of active upper respiratory disease at time of consent;
- Smoking more than 5 cigarettes or equivalent and not able to stop for 48 hours;
- Ability to discontinue chronic medications or nutraceuticals for 20 days or 5 half-lives of the agent, whichever is longer.
Treatment and study plan
32ppm Silver Particle
DrugOral silver dose of 32ppm
Placebo
DrugSterile Water No Silver
Primary outcomes
-
Change Sodium Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change Potassium Blood Levels
Time frame: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change in Chloride Blood Levels
Time frame: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change in Carbon Dioxide Blood Levels
Time frame: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Urea Nitrogen Blood Levels
Time frame: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Creatinine Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Glucose Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Alkaline Phosphatase Blood Level
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Aspartate Aminotransferase Blood Level
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Alanine Aminotransferase Blood Level
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change in Total Protein Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Total Bilirubin Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Albumin Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Calcium Blood Level
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In White Blood Count Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Red Blood Count Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Hemoglobin Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Hematocrit Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Mean Corpuscular Volume Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Platelet Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Granulocytes Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Lymphocytes Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Monocytes Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Basophils Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Change In Eosinophils Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
-
Cytochrome P450 Assay on Dextromethorphan in Participants
Time frame: 14 Days
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.
-
Cytochrome P450 Assay on Losartan in Participants
Time frame: 14 Days
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.
-
Cytochrome P450 Assay on Caffeine in Participants
Time frame: 14 Days
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.
-
Cytochrome P450 Assay on Omeprazole in Participants
Time frame: 14 Days
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.
-
Cytochrome P450 Assay on Midazolam in Participants
Time frame: 14 Days
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.
Secondary outcomes
-
Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver
Time frame: 14 Days
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.
-
Total Change in Systolic Blood Pressure Silver Participants
Time frame: Baseline and 14 Days
Assessment only completed on the 32ppm Oral Silver part of the trail
-
Total Change in Diastolic Blood Pressure Silver Participants
Time frame: Baseline and 14 Days
Assessment only completed on the 32ppm Oral Silver part of the trail
-
Total Change in Heart Rate in Silver Participants
Time frame: Baseline and 14 Days
Assessment only completed on the 32ppm Oral Silver part of the trail
Sponsors and collaborators
Lead sponsor
University of Utah
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Jul 29, 2011
- Registry last updated
- Jul 4, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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