Phase 2 N=12 Double-blind

In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01405794 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Oct 2015

Primary outcome: Primary: Change Sodium Blood Levels — 141.8; 141.2 mmol/L

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Change Sodium Blood Levels	141.8; 141.2	—
PRIMARY Change Potassium Blood Levels	4.5; 4.4	—
PRIMARY Change in Chloride Blood Levels	105.0; 105.5	—
PRIMARY Change in Carbon Dioxide Blood Levels	26.5; 26.8	—
PRIMARY Change In Urea Nitrogen Blood Levels	16.9; 16.7	—
PRIMARY Change In Creatinine Blood Levels	0.92; 0.88	—
PRIMARY Change In Glucose Blood Levels	85.9; 83.5	—
PRIMARY Change In Alkaline Phosphatase Blood Level	89.0; 85.4	—
PRIMARY Change In Aspartate Aminotransferase Blood Level	29.1; 30.9	—
PRIMARY Change In Alanine Aminotransferase Blood Level	36.1; 34.7	—
PRIMARY Change in Total Protein Blood Levels	7.1; 7.4	—
PRIMARY Change In Total Bilirubin Blood Levels	0.7; 0.8	—
PRIMARY Change In Albumin Blood Levels	4.3; 4.4	—
PRIMARY Change In Calcium Blood Level	9.4; 9.4	—
PRIMARY Change In White Blood Count Blood Levels	5.99; 5.92	—
PRIMARY Change In Red Blood Count Blood Levels	5.07; 5.07	—
PRIMARY Change In Hemoglobin Blood Levels	15.5; 15.5	—
PRIMARY Change In Hematocrit Blood Levels	45.0; 45.4	—
PRIMARY Change In Mean Corpuscular Volume Blood Levels	89.1; 89.6	—
PRIMARY Change In Mean Corpuscular Hemoglobin Concentration Blood Levels	34.5; 34.2	—
PRIMARY Change In Platelet Blood Levels	268; 253	—
PRIMARY Change In Granulocytes Blood Levels	52.6; 53.4	—
PRIMARY Change In Lymphocytes Blood Levels	36.7; 36.8	—
PRIMARY Change In Monocytes Blood Levels	6.4; 6.0	—
PRIMARY Change In Basophils Blood Levels	0.8; 0.7	—
PRIMARY Change In Eosinophils Blood Levels	3.4; 3.1	—
PRIMARY Cytochrome P450 Assay on Dextromethorphan in Participants	5.53; 2.18	—
PRIMARY Cytochrome P450 Assay on Losartan in Participants	1.62; 1.76	—
PRIMARY Cytochrome P450 Assay on Caffeine in Participants	3.34; 3.68	—
PRIMARY Cytochrome P450 Assay on Omeprazole in Participants	2.19; 1.81	—
PRIMARY Cytochrome P450 Assay on Midazolam in Participants	9.62; 9.18	—
SECONDARY Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver	2311; 1912	—
SECONDARY Total Change in Systolic Blood Pressure Silver Participants	-1.3	—
SECONDARY Total Change in Diastolic Blood Pressure Silver Participants	-0.7	—
SECONDARY Total Change in Heart Rate in Silver Participants	-3.1	—

Summary

The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.

Eligibility Criteria

Inclusion Criteria

18-80 years old without debilitating chronic disease or history of cardiovascular event.

Exclusion Criteria

Women physically capable of becoming pregnant, who are not using 2 barrier methods of birth control;
Any female who is nursing;
History of heavy metal allergy;
History of asthma or Chronic Obstructive Pulmonary Disease;
History of renal impairment;
Symptoms of active upper respiratory disease at time of consent;
Smoking more than 5 cigarettes or equivalent and not able to stop for 48 hours;
Ability to discontinue chronic medications or nutraceuticals for 20 days or 5 half-lives of the agent, whichever is longer.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01405794). 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.