In Vivo Assessment of Silver Biomaterial Nano-Toxicity
28. Juli 2015 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
36
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Utah
-
Salt Lake City, Utah, Vereinigte Staaten, 84132
- University of Utah Hospital and Clinics
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 10ppm Oral Silver
Oral Dose of 10ppm
|
Silver nanoparticles at 10ppm
|
|
Experimental: 32ppm Oral Silver
Oral Dose of 32ppm
|
Silver nanoparticles at 32ppm
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Sodium Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Potassium Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Chloride Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Carbon Dioxide Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Urea Nitrogen Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In CreatinineBlood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Glucose Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Alkaline Phosphatase Blood Level
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Aspartate Aminotransferase Blood Level
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Alanine Aminotransferase Blood Level
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Total Protein Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Total Bilirubin Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Albumin Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Calcium Blood Level
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In White Blood Count Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Red Blood Count Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Hemoglobin Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Hematocrit Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Mean Corpuscular Volume Blood Levels
Zeitfenster: 14 days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 days
|
|
Change In Mean Corpuscular Hemoglobin Blood Levels
Zeitfenster: 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
Zeitfenster: 14 days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 days
|
|
Change In Platelet Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Granulocytes Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Lymphocytes Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Monocytes Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Basophils Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Eosinophil Blood Levels
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Sputum Reactive Oxygen Species Change
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change to Interleukin-8 Receptor
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change to Interleukin-1 Alpha Receptor
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change to Interleukin-1 Beta Receptor
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Monocyte Chemotactic Protein 1
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Quinone Oxidoreductase 1 Gene
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change Systolic Blood Pressure
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Mean Change in Diastolic Blood Pressure
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Mean Change in Heart Rate
Zeitfenster: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Mark A Munger, Pharm.D>, University of Utah
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Dezember 2010
Primärer Abschluss (Tatsächlich)
1. Juli 2011
Studienabschluss (Tatsächlich)
1. Juli 2011
Studienanmeldedaten
Zuerst eingereicht
16. November 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. November 2010
Zuerst gepostet (Schätzen)
18. November 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
25. August 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. Juli 2015
Zuletzt verifiziert
1. Juli 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 40281
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .