In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 32ppm Silver Particle; Drug: Placebo

• Registration Number: NCT01405794
• Lead Sponsor: University of Utah

Brief Summary

The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2013-07-12
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-24
• Results First Posted: 2015-10-26
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 18-80 years old without debilitating chronic disease or history of cardiovascular event.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
32ppm Oral Silver	32ppm Silver Particle	14 Days Active Silver Solution
Sterile Water	Placebo	No Silver Nanoparticles

Primary Outcome Measures

Name	Time	Method
Change in Chloride Blood Levels	14 days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change Sodium Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Creatinine Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Alanine Aminotransferase Blood Level	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Total Protein Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Total Bilirubin Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Albumin Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Calcium Blood Level	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In White Blood Count Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Red Blood Count Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Hemoglobin Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Hematocrit Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Mean Corpuscular Volume Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Platelet Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Granulocytes Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Lymphocytes Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Monocytes Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Basophils Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Eosinophils Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Cytochrome P450 Assay on Dextromethorphan in Participants	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	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	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	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	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.
Change Potassium Blood Levels	14 days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Carbon Dioxide Blood Levels	14 days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Glucose Blood Levels	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Alkaline Phosphatase Blood Level	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Aspartate Aminotransferase Blood Level	14 Days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Urea Nitrogen Blood Levels	14 days	Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

Secondary Outcome Measures

Name	Time	Method
Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver	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	Baseline and 14 Days	Assessment only completed on the 32ppm Oral Silver part of the trail
Total Change in Diastolic Blood Pressure Silver Participants	Baseline and 14 Days	Assessment only completed on the 32ppm Oral Silver part of the trail
Total Change in Heart Rate in Silver Participants	Baseline and 14 Days	Assessment only completed on the 32ppm Oral Silver part of the trail

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States