Phase 2 N=36 Randomized Double-blind

In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01243320 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Aug 2015

Primary outcome: Primary: Change in Sodium Blood Levels — -0.1; 0.2 mmol/L

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 10ppm Oral Silver Particle (Drug); 32ppm Oral Silver Particle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Sodium Blood Levels	-0.1; 0.2	—
PRIMARY Change in Potassium Blood Levels	-0.1; -0.03	—
PRIMARY Change in Chloride Blood Levels	-0.4; 0.04	—
PRIMARY Change in Carbon Dioxide Blood Levels	0.5; -0.04	—
PRIMARY Change in Urea Nitrogen Blood Levels	-0.9; 0.5	—
PRIMARY Change In CreatinineBlood Levels	0.01; -0.02	—
PRIMARY Change In Glucose Blood Levels	3.6; -0.7	—
PRIMARY Change In Alkaline Phosphatase Blood Level	-1.4; 2.0	—
PRIMARY Change In Aspartate Aminotransferase Blood Level	-0.44; 2.0	—
PRIMARY Change In Alanine Aminotransferase Blood Level	-2.6; 2.3	—
PRIMARY Change In Total Protein Blood Levels	-0.02; 0.2	—
PRIMARY Change In Total Bilirubin Blood Levels	-0.02; -0.03	—
PRIMARY Change in Albumin Blood Levels	-0.07; 0.11	—
PRIMARY Change In Calcium Blood Level	-0.1; 0.1	—
PRIMARY Change In White Blood Count Blood Levels	-0.17; -0.09	—
PRIMARY Change In Red Blood Count Blood Levels	-0.08; 0.06	—
PRIMARY Change In Hemoglobin Blood Levels	-0.2; 0.1	—
PRIMARY Change In Hematocrit Blood Levels	-0.7; 0.8	—
PRIMARY Change In Mean Corpuscular Volume Blood Levels	0.1; 0.5	—
PRIMARY Change In Mean Corpuscular Hemoglobin Blood Levels	0.1; -0.01	—
PRIMARY Change In Mean Corpuscular Hemoglobin Concentration Blood Levels	0.1; -0.3	—
PRIMARY Change In Platelet Blood Levels	5; -4	—
PRIMARY Change In Granulocytes Blood Levels	-0.9; -0.7	—
PRIMARY Change In Lymphocytes Blood Levels	0.7; 1.3	—
PRIMARY Change In Monocytes Blood Levels	-0.1; -0.3	—
PRIMARY Change in Basophils Blood Levels	0.04; 0.001	—
PRIMARY Change in Eosinophil Blood Levels	-0.06; -0.2	—
PRIMARY Sputum Reactive Oxygen Species Change	0.89; -0.44	—
PRIMARY Change to Interleukin-8 Receptor	2.19; 6.39	—
PRIMARY Change to Interleukin-1 Alpha Receptor	-0.0005; 0.0197	—
PRIMARY Change to Interleukin-1 Beta Receptor	0.017; 0.027	—
PRIMARY Change in Monocyte Chemotactic Protein 1	-0.028; -0.004	—
PRIMARY Change in Quinone Oxidoreductase 1 Gene	-0.0043; -0.0279	—
SECONDARY Change Systolic Blood Pressure	1.3; -1.3	—
SECONDARY Mean Change in Diastolic Blood Pressure	-2.4; -0.7	—
SECONDARY Mean Change in Heart Rate	-1.9; -3.1	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01243320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.