In Vivo Assessment of Silver Biomaterial Nano-Toxicity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
mark munger, University of Utah
ClinicalTrials.gov Identifier:
NCT01243320
First received: November 16, 2010
Last updated: July 28, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: 10ppm Oral Silver Particle
Drug: 32ppm Oral Silver Particle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change in Sodium Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change in Potassium Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change in Chloride Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change in Carbon Dioxide Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change in Urea Nitrogen Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In CreatinineBlood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Glucose Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Alkaline Phosphatase Blood Level [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Aspartate Aminotransferase Blood Level [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Alanine Aminotransferase Blood Level [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Total Protein Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Total Bilirubin Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change in Albumin Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Calcium Blood Level [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In White Blood Count Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Red Blood Count Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Hemoglobin Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Hematocrit Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Mean Corpuscular Volume Blood Levels [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Mean Corpuscular Hemoglobin Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Mean Corpuscular Hemoglobin Concentration Blood Levels [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Platelet Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Granulocytes Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Lymphocytes Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change In Monocytes Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change in Basophils Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change in Eosinophil Blood Levels [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Sputum Reactive Oxygen Species Change [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change to Interleukin-8 Receptor [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change to Interleukin-1 Alpha Receptor [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change to Interleukin-1 Beta Receptor [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change in Monocyte Chemotactic Protein 1 [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Change in Quinone Oxidoreductase 1 Gene [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.


Secondary Outcome Measures:
  • Change Systolic Blood Pressure [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Mean Change in Diastolic Blood Pressure [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  • Mean Change in Heart Rate [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.


Enrollment: 36
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10ppm Oral Silver
Oral Dose of 10ppm
Drug: 10ppm Oral Silver Particle
Silver nanoparticles at 10ppm
Experimental: 32ppm Oral Silver
Oral Dose of 32ppm
Drug: 32ppm Oral Silver Particle
Silver nanoparticles at 32ppm

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be > 18-80 years old will be included.

Exclusion Criteria:

  • Females of child-bearing potential, defined as women physically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means will be excluded unless they are using 2 barrier birth control methods (i.e., diaphragm, condom, intrauterine device, sponge or spermicide) or hormonal contraceptive method.
  • Any female subject who is nursing will be excluded. Subject with has a history of heavy metal allergy (including silver) or a history of asthma or COPD or renal impairment defined by a creatinine clearance below 30 ml/min.
  • Subjects with symptoms of an active upper respiratory infection at time of consent will also be excluded.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01243320

Locations
United States, Utah
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Mark A Munger, Pharm.D> University of Utah
  More Information

No publications provided by University of Utah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: mark munger, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01243320     History of Changes
Other Study ID Numbers: 40281
Study First Received: November 16, 2010
Results First Received: June 4, 2015
Last Updated: July 28, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 27, 2015