In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 32ppm Oral Silver Particle; Drug: 10ppm Oral Silver Particle

• Registration Number: NCT01243320
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Study Start: 2010-12
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2015-06-04
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-28
• Last Update Submitted: 2015-07-28
• Results First Posted: 2015-08-25
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
32ppm Oral Silver	32ppm Oral Silver Particle	Oral Dose of 32ppm
10ppm Oral Silver	10ppm Oral Silver Particle	Oral Dose of 10ppm

Primary Outcome Measures

Name	Time	Method
Change in Potassium Blood Levels	14 Days	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
Change in Quinone Oxidoreductase 1 Gene	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 Glucose 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 Sodium 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 Alanine Aminotransferase Blood Level	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 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 Aspartate Aminotransferase Blood Level	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 Calcium Blood Level	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 Mean Corpuscular Volume Blood Levels	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 Platelet 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.
Change to Interleukin-1 Alpha Receptor	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 Total Protein 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 White Blood Count 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 to Interleukin-1 Beta Receptor	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 to Interleukin-8 Receptor	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.
Sputum Reactive Oxygen Species Change	14 Days	All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Utah Hospital and Clinics; 🇺🇸 Salt Lake City, Utah, United States