Clinical trial NCT01243320: In Vivo Assessment of Silver Biomaterial Nano-Toxicity
Official title: In Vivo Assessment of Silver Biomaterial Nano-Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


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.

Primary outcomes:
measure: Change in Sodium Blood Levels
timeFrame: 14 Days
measure: Change in Potassium Blood Levels
timeFrame: 14 Days
measure: Change in Chloride Blood Levels
timeFrame: 14 Days
measure: Change in Carbon Dioxide Blood Levels
timeFrame: 14 Days
measure: Change in Urea Nitrogen Blood Levels
timeFrame: 14 Days
measure: Change In CreatinineBlood Levels
timeFrame: 14 Days
measure: Change In Glucose Blood Levels
timeFrame: 14 Days
measure: Change In Alkaline Phosphatase Blood Level
timeFrame: 14 Days
measure: Change In Aspartate Aminotransferase Blood Level
timeFrame: 14 Days
measure: Change In Alanine Aminotransferase Blood Level
timeFrame: 14 Days
measure: Change In Total Protein Blood Levels
timeFrame: 14 Days
measure: Change In Total Bilirubin Blood Levels
timeFrame: 14 Days
measure: Change in Albumin Blood Levels
timeFrame: 14 Days
measure: Change In Calcium Blood Level
timeFrame: 14 Days
measure: Change In White Blood Count Blood Levels
timeFrame: 14 Days
measure: Change In Red Blood Count Blood Levels
timeFrame: 14 Days
measure: Change In Hemoglobin Blood Levels
timeFrame: 14 Days
measure: Change In Hematocrit Blood Levels
timeFrame: 14 Days
measure: Change In Mean Corpuscular Volume Blood Levels
timeFrame: 14 days
measure: Change In Mean Corpuscular Hemoglobin Blood Levels
timeFrame: 14 Days
measure: Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
timeFrame: 14 days
measure: Change In Platelet Blood Levels
timeFrame: 14 Days
measure: Change In Granulocytes Blood Levels
timeFrame: 14 Days
measure: Change In Lymphocytes Blood Levels
timeFrame: 14 Days
measure: Change In Monocytes Blood Levels
timeFrame: 14 Days
measure: Change in Basophils Blood Levels
timeFrame: 14 Days
measure: Change in Eosinophil Blood Levels
timeFrame: 14 Days
measure: Sputum Reactive Oxygen Species Change
timeFrame: 14 Days
measure: Change to Interleukin-8 Receptor
timeFrame: 14 Days
measure: Change to Interleukin-1 Alpha Receptor
timeFrame: 14 Days
measure: Change to Interleukin-1 Beta Receptor
timeFrame: 14 Days
measure: Change in Monocyte Chemotactic Protein 1
timeFrame: 14 Days
measure: Change in Quinone Oxidoreductase 1 Gene
timeFrame: 14 Days
Secondary outcomes:
measure: Change Systolic Blood Pressure
timeFrame: 14 Days
measure: Mean Change in Diastolic Blood Pressure
timeFrame: 14 Days
measure: Mean Change in Heart Rate
timeFrame: 14 Days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinics
state: Utah
Study officials:
affiliation: University of Utah
name: Mark A Munger, Pharm.D>
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munger MA, Radwanski P, Hadlock GC, Stoddard G, Shaaban A, Falconer J, Grainger DW, Deering-Rice CE. In vivo human time-exposure study of orally dosed commercial silver nanoparticles. Nanomedicine. 2014 Jan;10(1):1-9. doi: 10.1016/j.nano.2013.06.010. Epub 2013 Jun 28.