HealthyPhase 1/2NCT01243320

In Vivo Assessment of Silver Biomaterial Nano-Toxicity

A Phase 1/2 study testing 10ppm Oral Silver Particle and 32ppm Oral 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

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… 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?: 10ppm Oral Silver Particle and 32ppm Oral Silver Particle
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Dec 2010to Jul 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

Subjects must be > 18-80 years old will be included.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132

Other trials in United States

About this study

Conditions: Healthy
Being tested: 10ppm Oral Silver Particle, 32ppm Oral Silver Particle

What participants receive

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

10ppm Oral Silver ParticleDrug
Silver nanoparticles at 10ppm
32ppm Oral Silver ParticleDrug
Silver nanoparticles at 32ppm

Study groups in NCT01243320
Study group	Role	What they receive
10ppm Oral Silver	Experimental	Oral Dose of 10ppm Receives: Drug: 10ppm Oral Silver Particle
32ppm Oral Silver	Experimental	Oral Dose of 32ppm Receives: Drug: 32ppm Oral Silver Particle

What is being measured

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

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

Secondary outcomes (3)

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

Timeline

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

Dec 2010Jul 2011

First posted18 Nov 2010 (estimated)
Study startDec 2010
Primary completionJul 2011
Study completionJul 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: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01243320
Sponsor's protocol ID: 40281
Status last verified: Jul 2015
First submitted: 16 Nov 2010
Last updated: 25 Aug 2015
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 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vivo Assessment of Silver Biomaterial Nano-Toxicity
ClinicalTrials.gov ID: NCT01243320
Acronym / sponsor ID: 40281
Conditions: Healthy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Study start: Dec 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 18 Nov 2010 (estimated)
Results: Posted 25 Aug 2015

Clinical summary

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

Study design

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

Arm	Type	Receives
10ppm Oral Silver	Experimental	Drug: 10ppm Oral Silver ParticleOral Dose of 10ppm
32ppm Oral Silver	Experimental	Drug: 32ppm Oral Silver ParticleOral Dose of 32ppm

Who may qualify

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

Key inclusion criteria (1 listed)

Subjects must be > 18-80 years old will be included.

Key exclusion criteria (3 listed)

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.

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
10ppm Oral Silver ParticleSilver nanoparticles at 10ppm	Drug	10ppm Oral Silver
32ppm Oral Silver ParticleSilver nanoparticles at 32ppm	Drug	32ppm Oral Silver

Primary outcome

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

3 secondary outcomes

Change Systolic Blood Pressure
Time frame: 14 Days
Mean Change in Diastolic Blood Pressure
Time frame: 14 Days
Mean Change in Heart Rate
Time frame: 14 Days

Results and safety

Results posted to the registry on 25 Aug 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	36	36

Primary outcome: Change in Sodium Blood Levels

Time frame: 14 Days. Mean (95% Confidence Interval). Unit: mmol/L

Measure	10ppm Oral Silver n = 36	32ppm Oral Silver n = 24
Value	-0.1 (-0.7 to 0.6)	0.2 (-0.7 to 1.0)

Primary outcome: Change in Potassium Blood Levels

Time frame: 14 Days. Mean (95% Confidence Interval). Unit: mmol/L

Measure	10ppm Oral Silver n = 36	32ppm Oral Silver n = 24
Value	-0.1 (-0.3 to 0.02)	-0.03 (-0.2 to 0.1)

Primary outcome: Change in Chloride Blood Levels

Time frame: 14 Days. Mean (95% Confidence Interval). Unit: mmol/L

Measure	10ppm Oral Silver n = 36	32ppm Oral Silver n = 24
Value	-0.4 (-1.2 to 0.3)	0.04 (-1.1 to 1.2)

Primary outcome: Change in Carbon Dioxide Blood Levels

Time frame: 14 Days. Mean (95% Confidence Interval). Unit: mmol/L

Measure	10ppm Oral Silver n = 36	32ppm Oral Silver n = 24
Value	0.5 (-0.5 to 1.6)	-0.04 (-1.1 to 1.0)

3 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
10ppm Oral Solution	1 of 36 (2.8%)	0 of 36 (0%)	Not reported
32ppm Oral Solution	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
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 A 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 10ppm Oral Silver Particle and 32ppm Oral 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 3 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 25 Aug 2015. 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. 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 25 Aug 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 in Sodium Blood Levels (time frame: 14 Days). The study lists 33 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 NCT01243320, 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 25 Aug 2015.