In Vivo Assessment of Silver Biomaterial Nano-Toxicity

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 10ppm Oral Silver Particle; Drug: 32ppm Oral Silver Particle

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sodium Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change in Potassium Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change in Chloride Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change in Carbon Dioxide Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change in Urea Nitrogen Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In CreatinineBlood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Glucose Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Alkaline Phosphatase Blood Level	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Aspartate Aminotransferase Blood Level	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Alanine Aminotransferase Blood Level	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Total Protein Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Total Bilirubin Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change in Albumin Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Calcium Blood Level	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In White Blood Count Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Red Blood Count Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Hemoglobin Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Hematocrit Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Mean Corpuscular Volume Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 days
Change In Mean Corpuscular Hemoglobin Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 days
Change In Platelet Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Granulocytes Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Lymphocytes Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change In Monocytes Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change in Basophils Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change in Eosinophil Blood Levels	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Sputum Reactive Oxygen Species Change	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change to Interleukin-8 Receptor	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change to Interleukin-1 Alpha Receptor	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change to Interleukin-1 Beta Receptor	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change in Monocyte Chemotactic Protein 1	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Change in Quinone Oxidoreductase 1 Gene	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Systolic Blood Pressure	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Mean Change in Diastolic Blood Pressure	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days
Mean Change in Heart Rate	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.	14 Days

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Mark A Munger, Pharm.D>, University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 16, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 40281