HealthyNCT04144673
A Study Investigating the Safety and Efficacy of Bio-Active Silver Hydrosol™ in Providing Immune Support
A study testing Silver Hydrosol in people with Healthy, run by Natural Immunogenics Corp. at 1 site in Canada.
Trial summary
The objective of this study is to investigate the ability of Bio-Active Silver Hydrosol™ in providing immune support in healthy adult males and females participating in intense aerobic exercise. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Silver Hydrosol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 14 Nov 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provided voluntary, written, informed consent to participate in the study
- Females and males between 19 and 65 years of age inclusive
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
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- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- BMI between 18.5 to 29.9 kg/m2 inclusive
- Individuals participating in an intense aerobic sport (e.g. cycling, running, triathlon, swimming, soccer, Nordic skiing, basketball, hockey, gym etc.) for greater than or equal to 5 hours a week
- Agrees to provide a verbal history of flu vaccination
- Healthy as determined by laboratory results, medical history, and physical exam or as determined by the QI
- Agrees to maintain current diet and exercise programs
- Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Subject has a known allergy to the test material's active or inactive ingredients
- Verbal confirmation of a diagnosed chronic inflammatory condition
- Verbal confirmation of the diagnosis of any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis)
- Chronic consumption of oral anti-inflammatory medications such as cyclosporine for skin conditions such as psoriasis, dermatitis, rosacea
- Chronic consumption of anti-inflammatory medications or medications known to affect immune function on a daily basis, including medications for allergies and asthma with the exception of Ventolin, within 4 weeks of baseline visit (visit 2)
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- Verbal confirmation of chronic recurring respiratory signs and symptoms due to allergies (including seasonal allergies) or chronic bronchitis
- Verbal confirmation of active shingles and/or herpes virus infections, within 2 months of baseline
- Use of medical marijuana including THC-free CBD (any form of consumption)
- Use of recreational marijuana (any form of consumption) within the past 4 weeks and is unwilling to stop use for the duration of the study
- Use of immunomodulators (including corticosteroids) such as immunosuppressant or immune-stimulant medications within 4 weeks of baseline
- Taking antibiotics within 2 weeks of screening
- Use of immune support supplements unless willing to undergo washout
- Use of multivitamins unless on a stable regimen for 3 months as assessed by QI
- Verbal confirmation of Type I or Type II diabetes or clinically important hepatic, cardiac, pulmonary, pancreatic, neurologic, or biliary disorder
- History or current diagnosis of renal disease with the exception of a history of kidney stones symptom-free for 1 year
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Current or pre-existing thyroid condition. Treatment on a stable dose medication for 6 months will be reviewed on a case-by-case basis by the QI
- History of or current blood/bleeding disorders with the exception of a history of anemia caused by a deficiency of a mineral or vitamin, and no longer present.
- Verbal confirmation of the diagnosis of Hepatitis B/C positive
- Chronic unusual sleep routine (examples: irregular routine with frequent late nights, studying, partying)
- Use of Prebiotics and Probiotics unless on a stable regimen for 3 months as assessed by QI.
- Smoking study participants must be willing to abstain from tobacco use in the morning of a clinical visit
- High alcohol intake (average >2 standard drinks per day, or ≥15 standard drinks per week for men, or ≥8 standard drinks per week for women)
- Alcohol or drug abuse in the past year
- Blood donation during or within 30 days of the last study visit
- Subjects with unstable medical conditions as assessed by the QI
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Participation in a clinical research trial within 30 days prior to randomization
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the QI's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose a significant risk to the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Safety and Efficacy of Bio-Active Silver Hydrosol™ in Providing Immune Support
The objective of this study is to investigate the ability of Bio-Active Silver Hydrosol™ in providing immune support in healthy adult males and females participating in intense aerobic exercise. Sixty eligible participants are planned to be randomized into either the investigational product or treatments arms and will consume the study product for 60 days (check-in visit on day 28). Questionnaires will be completed and blood and saliva samples will be collected to measure the endpoints.
- Conditions
- Healthy
- Being tested
- Silver Hydrosol, Placebo
- Keywords
- Immune Support, Active lifestyle, Silver, Healthy Adults, Cold, WURSS
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver HydrosolOther
Also called Sovereign Silver, Bio-Active Silver Hydrosol™
Silver quantity will be 7 doses per day, with 50 mcg per dose.
PlaceboOther
Placebo water with no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | Not described Receives: Other: Silver Hydrosol |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between Bio-Active Silver Hydrosol™ and placebo in the mean global severity index, as measured by area under the curve (AUC) for the WURSS-24 daily symptom scores after 60 days supplementation.
The Wisconsin Upper Respiratory Symptom Survey (WURSS) is a questionnaire used to evaluate the negative impact of acute URTIs. The WURSS-24 contains 24 items scored on a Likert-type severity scale. It contains the same items as the WURSS-21 along with headache, body ache, and fever to capture influenza-like illness symptoms. The items are scored on a 0 (do not have this symptom) to 7 (severe) scale.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start14 Nov 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immunogenics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144673
- Sponsor's protocol ID
- 19SIHN
- Status last verified
- Apr 2021
- First submitted
- 28 Oct 2019
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barrett B, Brown RL, Mundt MP, Thomas GR, Barlow SK, Highstrom AD, Bahrainian M. Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Health Qual Life Outcomes. 2009 Aug 12;7:76. doi: 10.1186/1477-7525-7-76.
PubMed 19674476
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Safety and Efficacy of Bio-Active Silver Hydrosol™ in Providing Immune Support
- ClinicalTrials.gov ID
- NCT04144673
- Acronym / sponsor ID
- 19SIHN
- Conditions
- Healthy
- Keywords
- Immune Support, Active lifestyle, Silver, Healthy Adults, Cold, WURSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Natural Immunogenics Corp.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the ability of Bio-Active Silver Hydrosol™ in providing immune support in healthy adult males and females participating in intense aerobic exercise. Sixty eligible participants are planned to be randomized into either the investigational product or treatments arms and will consume the study product for 60 days (check-in visit on day 28). Questionnaires will be completed and blood and saliva samples will be collected to measure the endpoints.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel study
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Other: Silver Hydrosol |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provided voluntary, written, informed consent to participate in the study
- Females and males between 19 and 65 years of age inclusive
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening Or,
- BMI between 18.5 to 29.9 kg/m2 inclusive
- Individuals participating in an intense aerobic sport (e.g. cycling, running, triathlon, swimming, soccer, Nordic skiing, basketball, hockey, gym etc.) for greater than or equal to 5 hours a week
Key exclusion criteria (31 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Subject has a known allergy to the test material's active or inactive ingredients
- Verbal confirmation of a diagnosed chronic inflammatory condition
- Verbal confirmation of the diagnosis of any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis)
- Chronic consumption of oral anti-inflammatory medications such as cyclosporine for skin conditions such as psoriasis, dermatitis, rosacea
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 |
|---|---|---|
| Silver HydrosolAlso: Sovereign Silver, Bio-Active Silver Hydrosol™Silver quantity will be 7 doses per day, with 50 mcg per dose. | Other | Investigational Product |
| PlaceboPlacebo water with no active ingredients | Other | Placebo |
Primary outcome
The difference between Bio-Active Silver Hydrosol™ and placebo in the mean global severity index, as measured by area under the curve (AUC) for the WURSS-24 daily symptom scores after 60 days supplementation.
Time frame: 60 days
The Wisconsin Upper Respiratory Symptom Survey (WURSS) is a questionnaire used to evaluate the negative impact of acute URTIs. The WURSS-24 contains 24 items scored on a Likert-type severity scale. It contains the same items as the WURSS-21 along with headache, body ache, and fever to capture influenza-like illness symptoms. The items are scored on a 0 (do not have this symptom) to 7 (severe) scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Background: PubMed 19674476Barrett B, Brown RL, Mundt MP, Thomas GR, Barlow SK, Highstrom AD, Bahrainian M. Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Health Qual Life Outcomes. 2009 Aug 12;7:76. doi: 10.1186/1477-7525-7-76.
- Explains the development of the WURSS-24 from the WURSS-21Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Hydrosol in people with Healthy, run by Natural Immunogenics Corp. at 1 site in Canada.
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 15 inclusion and 31 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 23 Apr 2021. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference between Bio-Active Silver Hydrosol™ and placebo in the mean global severity index, as measured by area under the curve (AUC) for the WURSS-24 daily symptom scores after 60 days supplementation. (time frame: 60 days). 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 NCT04144673, 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 23 Apr 2021.