In Vivo Assessment of Silver Biomaterial Nano-Toxicity
28 juli 2015 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84132
- University of Utah Hospital and Clinics
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 10ppm Oral Silver
Oral Dose of 10ppm
|
Silver nanoparticles at 10ppm
|
|
Experimentell: 32ppm Oral Silver
Oral Dose of 32ppm
|
Silver nanoparticles at 32ppm
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Sodium Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Potassium Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Chloride Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Carbon Dioxide Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Urea Nitrogen Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In CreatinineBlood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Glucose Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Alkaline Phosphatase Blood Level
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Aspartate Aminotransferase Blood Level
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Alanine Aminotransferase Blood Level
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Total Protein Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Total Bilirubin Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Albumin Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Calcium Blood Level
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In White Blood Count Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Red Blood Count Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Hemoglobin Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Hematocrit Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Mean Corpuscular Volume Blood Levels
Tidsram: 14 days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 days
|
|
Change In Mean Corpuscular Hemoglobin Blood Levels
Tidsram: 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
Tidsram: 14 days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 days
|
|
Change In Platelet Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Granulocytes Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Lymphocytes Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change In Monocytes Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Basophils Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Eosinophil Blood Levels
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Sputum Reactive Oxygen Species Change
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change to Interleukin-8 Receptor
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change to Interleukin-1 Alpha Receptor
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change to Interleukin-1 Beta Receptor
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Monocyte Chemotactic Protein 1
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Change in Quinone Oxidoreductase 1 Gene
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change Systolic Blood Pressure
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Mean Change in Diastolic Blood Pressure
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
|
Mean Change in Heart Rate
Tidsram: 14 Days
|
All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
|
14 Days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mark A Munger, Pharm.D>, University of Utah
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2010
Primärt slutförande (Faktisk)
1 juli 2011
Avslutad studie (Faktisk)
1 juli 2011
Studieregistreringsdatum
Först inskickad
16 november 2010
Först inskickad som uppfyllde QC-kriterierna
17 november 2010
Första postat (Uppskatta)
18 november 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
25 augusti 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juli 2015
Senast verifierad
1 juli 2015
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 40281
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .