In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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10ppm Oral Silver

Oral Dose of 10ppm

Group Type EXPERIMENTAL

10ppm Oral Silver Particle

Intervention Type DRUG

Silver nanoparticles at 10ppm

32ppm Oral Silver

Oral Dose of 32ppm

Group Type EXPERIMENTAL

32ppm Oral Silver Particle

Intervention Type DRUG

Silver nanoparticles at 32ppm

Interventions

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10ppm Oral Silver Particle

Silver nanoparticles at 10ppm

Intervention Type DRUG

32ppm Oral Silver Particle

Silver nanoparticles at 32ppm

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes