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Completed

NCT Number: NCT01243320

In Vivo Assessment of Silver Biomaterial Nano-Toxicity

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10ppm Oral Silver Particle

Drug

Silver nanoparticles at 10ppm

32ppm Oral Silver Particle

Drug

Silver nanoparticles at 32ppm

Primary outcomes

  1. Change in Sodium Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  2. Change in Potassium Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  3. Change in Chloride Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  4. Change in Carbon Dioxide Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  5. Change in Urea Nitrogen Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  6. Change In CreatinineBlood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  7. Change In Glucose Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  8. Change In Alkaline Phosphatase Blood Level

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  9. Change In Aspartate Aminotransferase Blood Level

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  10. Change In Alanine Aminotransferase Blood Level

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  11. Change In Total Protein Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  12. Change In Total Bilirubin Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  13. Change in Albumin Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  14. Change In Calcium Blood Level

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  15. Change In White Blood Count Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  16. Change In Red Blood Count Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  17. Change In Hemoglobin Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  18. Change In Hematocrit Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  19. Change In Mean Corpuscular Volume Blood Levels

    Time frame: 14 days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  20. Change In Mean Corpuscular Hemoglobin Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  21. Change In Mean Corpuscular Hemoglobin Concentration Blood Levels

    Time frame: 14 days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  22. Change In Platelet Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  23. Change In Granulocytes Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  24. Change In Lymphocytes Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  25. Change In Monocytes Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  26. Change in Basophils Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  27. Change in Eosinophil Blood Levels

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  28. Sputum Reactive Oxygen Species Change

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  29. Change to Interleukin-8 Receptor

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  30. Change to Interleukin-1 Alpha Receptor

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  31. Change to Interleukin-1 Beta Receptor

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  32. Change in Monocyte Chemotactic Protein 1

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  33. Change in Quinone Oxidoreductase 1 Gene

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

Secondary outcomes

  1. Change Systolic Blood Pressure

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  2. Mean Change in Diastolic Blood Pressure

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

  3. Mean Change in Heart Rate

    Time frame: 14 Days

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 18, 2010
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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