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

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Drug: 32ppm Silver Particle; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01405794

50310

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

12 participants in 2 patient groups, including a placebo group

32ppm Oral Silver

Experimental group

Description:

14 Days Active Silver Solution

Treatment:

Drug: 32ppm Silver Particle

Sterile Water

Placebo Comparator group

Description:

No Silver Nanoparticles

Treatment:

Drug: Placebo