In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01243320

Enrollment

Registered

2010-11-18

Start date

2010-12-31

Completion date

2011-07-31

Last updated

2015-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUG10ppm Oral Silver Particle

Silver nanoparticles at 10ppm

DRUG32ppm Oral Silver Particle

Silver nanoparticles at 32ppm

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
All Study Participants 10 ppm Silver, then 32 ppm Silver	36
Total	36

Baseline characteristics

Characteristic	All Study Participants
Age, Continuous	47 years STANDARD_DEVIATION 14
Sex: Female, Male Female	17 Participants
Sex: Female, Male Male	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 36	0 / 24
serious Total, serious adverse events	1 / 36	0 / 24