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In Vivo Assessment of Silver Biomaterial Nano-Toxicity

28. juli 2015 oppdatert av: mark munger, University of Utah
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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

36

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
        • University of Utah Hospital and Clinics

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 10ppm Oral Silver
Oral Dose of 10ppm
Legemiddel: 10ppm Oral Silver Particle
Silver nanoparticles at 10ppm
Eksperimentell: 32ppm Oral Silver
Oral Dose of 32ppm
Legemiddel: 32ppm Oral Silver Particle
Silver nanoparticles at 32ppm

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Sodium Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Potassium Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Chloride Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Carbon Dioxide Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Urea Nitrogen Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In CreatinineBlood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Glucose Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Alkaline Phosphatase Blood Level
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Aspartate Aminotransferase Blood Level
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Alanine Aminotransferase Blood Level
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Total Protein Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Total Bilirubin Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Albumin Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Calcium Blood Level
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In White Blood Count Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Red Blood Count Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Hemoglobin Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Hematocrit Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Mean Corpuscular Volume Blood Levels
Tidsramme: 14 days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 days
Change In Mean Corpuscular Hemoglobin Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
Tidsramme: 14 days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 days
Change In Platelet Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Granulocytes Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Lymphocytes Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change In Monocytes Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Basophils Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Eosinophil Blood Levels
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Sputum Reactive Oxygen Species Change
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change to Interleukin-8 Receptor
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change to Interleukin-1 Alpha Receptor
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change to Interleukin-1 Beta Receptor
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Monocyte Chemotactic Protein 1
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Change in Quinone Oxidoreductase 1 Gene
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change Systolic Blood Pressure
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Mean Change in Diastolic Blood Pressure
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days
Mean Change in Heart Rate
Tidsramme: 14 Days
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
14 Days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Utah

Etterforskere

  • Hovedetterforsker: Mark A Munger, Pharm.D>, University of Utah

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2010

Primær fullføring (Faktiske)

1. juli 2011

Studiet fullført (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først innsendt

16. november 2010

Først innsendt som oppfylte QC-kriteriene

17. november 2010

Først lagt ut (Anslag)

18. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. august 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2015

Sist bekreftet

1. juli 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 40281

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