HealthyPhase 1/2NCT01405794

In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm

A Phase 1/2 study testing 32ppm Silver Particle in people with Healthy, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: 32ppm Silver Particle
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Nov 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18-80 years old without debilitating chronic disease or history of cardiovascular event.

Who cannot join

Women physically capable of becoming pregnant, who are not using 2 barrier methods of birth control;
Any female who is nursing;
History of heavy metal allergy;
History of asthma or Chronic Obstructive Pulmonary Disease;
History of renal impairment;
Symptoms of active upper respiratory disease at time of consent;
Smoking more than 5 cigarettes or equivalent and not able to stop for 48 hours;
Ability to discontinue chronic medications or nutraceuticals for 20 days or 5 half-lives of the agent, whichever is longer.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Utah
Salt Lake City, Utah, 84112-5820

Other trials in United States

About this study

The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.

Conditions: Healthy
Being tested: 32ppm Silver Particle, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

32ppm Silver ParticleDrug
Oral silver dose of 32ppm
PlaceboDrug
Sterile Water No Silver

Study groups in NCT01405794
Study group	Role	What they receive
32ppm Oral Silver	Experimental	14 Days Active Silver Solution Receives: Drug: 32ppm Silver Particle
Sterile Water	Placebo comparator	No Silver Nanoparticles Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change Sodium Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change Potassium Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 days
Change in Chloride Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 days
Change in Carbon Dioxide Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 days
Change In Urea Nitrogen Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 days
Change In Creatinine Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Glucose Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Alkaline Phosphatase Blood Level
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Aspartate Aminotransferase Blood Level
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Alanine Aminotransferase Blood Level
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change in Total Protein Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Total Bilirubin Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Albumin Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Calcium Blood Level
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In White Blood Count Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Red Blood Count Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Hemoglobin Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Hematocrit Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Mean Corpuscular Volume Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Platelet Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Granulocytes Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Lymphocytes Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Monocytes Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Basophils Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Change In Eosinophils Blood Levels
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Measured: 14 Days
Cytochrome P450 Assay on Dextromethorphan in Participants
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Measured: 14 Days
Cytochrome P450 Assay on Losartan in Participants
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Measured: 14 Days
Cytochrome P450 Assay on Caffeine in Participants
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Measured: 14 Days
Cytochrome P450 Assay on Omeprazole in Participants
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Measured: 14 Days
Cytochrome P450 Assay on Midazolam in Participants
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Measured: 14 Days

Secondary outcomes (4)

Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Measured: 14 Days
Total Change in Systolic Blood Pressure Silver Participants
Assessment only completed on the 32ppm Oral Silver part of the trail
Measured: Baseline and 14 Days
Total Change in Diastolic Blood Pressure Silver Participants
Assessment only completed on the 32ppm Oral Silver part of the trail
Measured: Baseline and 14 Days
Total Change in Heart Rate in Silver Participants
Assessment only completed on the 32ppm Oral Silver part of the trail
Measured: Baseline and 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Nov 2011

First posted29 Jul 2011 (estimated)
Study startJul 2011
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of UtahThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Allocation: Non-randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01405794
Sponsor's protocol ID: 50310
Status last verified: Sep 2015
First submitted: 19 Jul 2011
Last updated: 4 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Munger MA, Radwanski P, Hadlock GC, Stoddard G, Shaaban A, Falconer J, Grainger DW, Deering-Rice CE. In vivo human time-exposure study of orally dosed commercial silver nanoparticles. Nanomedicine. 2014 Jan;10(1):1-9. doi: 10.1016/j.nano.2013.06.010. Epub 2013 Jun 28.
PubMed 23811290

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm
ClinicalTrials.gov ID: NCT01405794
Acronym / sponsor ID: 50310
Conditions: Healthy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Study start: Jul 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 29 Jul 2011 (estimated)
Results: Posted 26 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.

Study design

Allocation: Non-randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
32ppm Oral Silver	Experimental	Drug: 32ppm Silver Particle14 Days Active Silver Solution
Sterile Water	Placebo comparator	Drug: PlaceboNo Silver Nanoparticles

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

18-80 years old without debilitating chronic disease or history of cardiovascular event.

Key exclusion criteria (8 listed)

Women physically capable of becoming pregnant, who are not using 2 barrier methods of birth control;
Any female who is nursing;
History of heavy metal allergy;
History of asthma or Chronic Obstructive Pulmonary Disease;
History of renal impairment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
32ppm Silver ParticleOral silver dose of 32ppm	Drug	32ppm Oral Silver
PlaceboSterile Water No Silver	Drug	Sterile Water

Primary outcome

Change Sodium Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change Potassium Blood Levels
Time frame: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Chloride Blood Levels
Time frame: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Carbon Dioxide Blood Levels
Time frame: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Urea Nitrogen Blood Levels
Time frame: 14 days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Creatinine Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Glucose Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Alkaline Phosphatase Blood Level
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Aspartate Aminotransferase Blood Level
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Alanine Aminotransferase Blood Level
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change in Total Protein Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Total Bilirubin Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Albumin Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Calcium Blood Level
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In White Blood Count Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Red Blood Count Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Hemoglobin Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Hematocrit Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Mean Corpuscular Volume Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Mean Corpuscular Hemoglobin Concentration Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Platelet Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Granulocytes Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Lymphocytes Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Monocytes Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Basophils Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Change In Eosinophils Blood Levels
Time frame: 14 Days
Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)
Cytochrome P450 Assay on Dextromethorphan in Participants
Time frame: 14 Days
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Cytochrome P450 Assay on Losartan in Participants
Time frame: 14 Days
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Cytochrome P450 Assay on Caffeine in Participants
Time frame: 14 Days
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Cytochrome P450 Assay on Omeprazole in Participants
Time frame: 14 Days
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.
Cytochrome P450 Assay on Midazolam in Participants
Time frame: 14 Days
Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.

4 secondary outcomes

Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver
Time frame: 14 Days
Total Change in Systolic Blood Pressure Silver Participants
Time frame: Baseline and 14 Days
Total Change in Diastolic Blood Pressure Silver Participants
Time frame: Baseline and 14 Days
Total Change in Heart Rate in Silver Participants
Time frame: Baseline and 14 Days

Results and safety

Results posted to the registry on 26 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	12	12

Primary outcome: Change Sodium Blood Levels

Time frame: 14 Days. Mean (Standard Deviation). Unit: mmol/L

Measure	Placebo n = 12	32ppm Oral Silver n = 12
Value	141.8 (1.6)	141.2 (1.9)

Primary outcome: Change Potassium Blood Levels

Time frame: 14 days. Mean (Standard Deviation). Unit: mmol/L

Measure	Placebo n = 12	32ppm Oral Silver n = 12
Value	4.5 (0.4)	4.4 (0.3)

Primary outcome: Change in Chloride Blood Levels

Time frame: 14 days. Mean (Standard Deviation). Unit: mmol/L

Measure	Placebo n = 12	32ppm Oral Silver n = 12
Value	105.0 (2.4)	105.5 (2.3)

Primary outcome: Change in Carbon Dioxide Blood Levels

Time frame: 14 days. Mean (Standard Deviation). Unit: mmol/L

Measure	Placebo n = 12	32ppm Oral Silver n = 12
Value	26.5 (2.3)	26.8 (2.2)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ASAP 32 Ppm Solution Experimental	0 of 12 (0%)	0 of 12 (0%)	Not reported
Silver Biotics 32 Ppm Diluent	1 of 12 (8.3%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23811290Munger MA, Radwanski P, Hadlock GC, Stoddard G, Shaaban A, Falconer J, Grainger DW, Deering-Rice CE. In vivo human time-exposure study of orally dosed commercial silver nanoparticles. Nanomedicine. 2014 Jan;10(1):1-9. doi: 10.1016/j.nano.2013.06.010. Epub 2013 Jun 28.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Munger, Pharm.D. principal investigator

University of Utah

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 32ppm Silver Particle in people with Healthy, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change Sodium Blood Levels (time frame: 14 Days). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01405794, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.