In Vivo Assessment of Silver Biomaterial Nano-Toxicity
28. juli 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah Hospital and Clinics
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 10ppm Oral Silver
Oral Dose of 10ppm
|
Silver nanoparticles at 10ppm
|
|
Eksperimentel: 32ppm Oral Silver
Oral Dose of 32ppm
|
Silver nanoparticles at 32ppm
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Mark A Munger, Pharm.D>, University of Utah
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2010
Primær færdiggørelse (Faktiske)
1. juli 2011
Studieafslutning (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først indsendt
16. november 2010
Først indsendt, der opfyldte QC-kriterier
17. november 2010
Først opslået (Skøn)
18. november 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. august 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 40281
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .