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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
mark munger, University of Utah
ClinicalTrials.gov Identifier:
NCT01405794
First received: July 19, 2011
Last updated: May 25, 2016
Last verified: September 2015
  Purpose
The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.

Condition Intervention Phase
Healthy
Drug: 32ppm Silver Particle
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change Sodium Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change Potassium Blood Levels [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change in Chloride Blood Levels [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change in Carbon Dioxide Blood Levels [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Urea Nitrogen Blood Levels [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Creatinine Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Glucose Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Alkaline Phosphatase Blood Level [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Aspartate Aminotransferase Blood Level [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Alanine Aminotransferase Blood Level [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change in Total Protein Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Total Bilirubin Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Albumin Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Calcium Blood Level [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In White Blood Count Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Red Blood Count Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Hemoglobin Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Hematocrit Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Mean Corpuscular Volume Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Mean Corpuscular Hemoglobin Concentration Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Platelet Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Granulocytes Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Lymphocytes Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Monocytes Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Basophils Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Change In Eosinophils Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)

  • Cytochrome P450 Assay on Dextromethorphan in Participants [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessment only completed on the 32ppm Oral Silver part of the trail


Enrollment: 12
Study Start Date: July 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 32ppm Oral Silver
14 Days Active Silver Solution
Drug: 32ppm Silver Particle
Oral silver dose of 32ppm
Placebo Comparator: Sterile Water
No Silver Nanoparticles
Drug: Placebo
Sterile Water No Silver

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405794

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112-5820
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Mark Munger, Pharm.D. University of Utah
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: mark munger, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01405794     History of Changes
Other Study ID Numbers: 50310 
Study First Received: July 19, 2011
Results First Received: July 12, 2013
Last Updated: May 25, 2016
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 23, 2016