In Vivo Assessment of Silver Biomaterial Nano-Toxicity

July 28, 2015 updated by: mark munger, University of Utah
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Sodium Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Potassium Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Chloride Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Carbon Dioxide Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Urea Nitrogen Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In CreatinineBlood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Glucose Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Alkaline Phosphatase Blood Level
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Aspartate Aminotransferase Blood Level
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Alanine Aminotransferase Blood Level
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Total Protein Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Total Bilirubin Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Albumin Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Calcium Blood Level
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In White Blood Count Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Red Blood Count Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Hemoglobin Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Hematocrit Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Mean Corpuscular Volume Blood Levels
Time Frame: 14 days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 days
Change In Mean Corpuscular Hemoglobin Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
Time Frame: 14 days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 days
Change In Platelet Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Granulocytes Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Lymphocytes Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Monocytes Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Basophils Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Eosinophil Blood Levels
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Sputum Reactive Oxygen Species Change
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change to Interleukin-8 Receptor
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change to Interleukin-1 Alpha Receptor
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change to Interleukin-1 Beta Receptor
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Monocyte Chemotactic Protein 1
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Quinone Oxidoreductase 1 Gene
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change Systolic Blood Pressure
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Mean Change in Diastolic Blood Pressure
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Mean Change in Heart Rate
Time Frame: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark A Munger, Pharm.D>, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 40281

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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