No ConditionsVITASTIQNCT03399240
Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
A study testing Vitasitiq device in people with No Conditions, run by Vitastiq d.o.o. at 1 site in Slovenia.
Trial summary
This is a single site evaluation study of Vitastiq device accuracy in healthy men and women in ratio 1:1 (approximately) aged between 18 and 64 years. A total of 45 Vitastiq personal devices will be used by volunteers for two months. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- No Conditions
- What is being tested?
- Vitasitiq device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSlovenia
- Study dates
- 17 May 2017to 2 Nov 2017
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent form (ICF) is signed by a volunteer
- Age between 18 and 64 years at the time of the signature of ICF
- A body mass index (BMI) between 18 and 28 kg/m2
- Healthy, meaning absence of any chronic or acute medical therapy for a month prior to the inclusion to the study
- Willing to follow all study procedures, including attending all site visits, and keeping a food diary and diary of activities on a weekly basis
Who cannot join
- Intake of any drugs to treat chronic disease within 1 month before the beginning and during the study
- Intake of any drugs to treat serious acute disease within 1 month before the beginning of the study and within 5 days of each visit
- Any clinically significant medical history of serious digestive tract, liver, kidney, skin or haematological disease or hormone imbalance
- Pregnant and breastfeeding women
- Women who planning pregnancy during the study
- Inadequate veins (in the opinion of the investigator)
Show all 10Show fewer
- Known drug or alcohol abuse
- Using any form of nicotine or tobacco
- Mental incapacity that precludes adequate understanding or cooperation
- Participation in another investigational study or blood donation within 3 months prior to or during this study
Trial locations and contacts
1 site in 1 country.
About this study
This is a single site evaluation study of Vitastiq device accuracy in healthy men and women in ratio 1:1 (approximately) aged between 18 and 64 years. A total of 45 Vitastiq personal devices will be used by volunteers for two months. The Vitastiq device will be evaluated during three site visits: on day 1, 29 ± 4 days and 57 ± 4 days. During site visit days, blood sampling will be collected and analysed and readings using Vitastiq device will be performed. Data will be analysed retrospectively to evaluate Vitastiq performance compared to blood tests results.
- Conditions
- No Conditions
- Being tested
- Vitasitiq device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitasitiq deviceDevice
Participant uses Vitastiq device for about 2 months to perform Vitastiq readings every day, preferably in the morning. On day 1, 29 and 57 participants' blood sampling is collected and analysed, and measurements using Vitastiq device are performed.
| Study group | Role | What they receive |
|---|---|---|
| Vitastiq device | Experimental | Vitastiq device is used for about 2 months to perform Vitastiq readings every day, preferably in the morning. Receives: Device: Vitasitiq device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitastiq device accuracy and performance
Vitastiq accuracy performance is at least 70% meaning that at least 70% of Vitastiq readings for each mineral and vitamin fall within the range of matching blood test results.
Measured: 30 minutes
Secondary outcomes (1)
Vitastiq readings method is repeatable
Vitastiq readings method is at least 80% repeatable. It means that at least 80% of Vitastiq readings for each mineral and vitamin performed by investigators and participant in the time frame of 30 minutes are comparable.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start17 May 2017
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitastiq d.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MEDEDUS, Ljubljana, Slovenia, Adria Lab, Ljubljana, Slovenia, Vizera d.o.o., Faculty of Pharmacy, Ljubljana, Slovenia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399240
- Sponsor's protocol ID
- Vita-01
- Acronym
- VITASTIQ
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2018
- Last updated
- 16 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
- ClinicalTrials.gov ID
- NCT03399240
- Acronym / sponsor ID
- VITASTIQ / Vita-01
- Conditions
- No Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vitastiq d.o.o.Industry (pharma, biotech, devices)
- Collaborators
- MEDEDUS, Ljubljana, Slovenia, Adria Lab, Ljubljana, Slovenia, Vizera d.o.o., Faculty of Pharmacy, Ljubljana, Slovenia
- Study start
- 17 May 2017 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 16 Jan 2018 (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.
This is a single site evaluation study of Vitastiq device accuracy in healthy men and women in ratio 1:1 (approximately) aged between 18 and 64 years. A total of 45 Vitastiq personal devices will be used by volunteers for two months. The Vitastiq device will be evaluated during three site visits: on day 1, 29 ± 4 days and 57 ± 4 days. During site visit days, blood sampling will be collected and analysed and readings using Vitastiq device will be performed. Data will be analysed retrospectively to evaluate Vitastiq performance compared to blood tests results.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitastiq device | Experimental | Device: Vitasitiq deviceVitastiq device is used for about 2 months to perform Vitastiq readings every day, preferably in the morning. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent form (ICF) is signed by a volunteer
- Age between 18 and 64 years at the time of the signature of ICF
- A body mass index (BMI) between 18 and 28 kg/m2
- Healthy, meaning absence of any chronic or acute medical therapy for a month prior to the inclusion to the study
- Willing to follow all study procedures, including attending all site visits, and keeping a food diary and diary of activities on a weekly basis
Key exclusion criteria (10 listed)
- Intake of any drugs to treat chronic disease within 1 month before the beginning and during the study
- Intake of any drugs to treat serious acute disease within 1 month before the beginning of the study and within 5 days of each visit
- Any clinically significant medical history of serious digestive tract, liver, kidney, skin or haematological disease or hormone imbalance
- Pregnant and breastfeeding women
- Women who planning pregnancy during the study
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 |
|---|---|---|
| Vitasitiq deviceParticipant uses Vitastiq device for about 2 months to perform Vitastiq readings every day, preferably in the morning. On day 1, 29 and 57 participants' blood sampling is collected and analysed, and measurements using Vitastiq device are performed. | Device | Vitastiq device |
Primary outcome
Vitastiq device accuracy and performance
Time frame: 30 minutes
Vitastiq accuracy performance is at least 70% meaning that at least 70% of Vitastiq readings for each mineral and vitamin fall within the range of matching blood test results.
1 secondary outcome
Vitastiq readings method is repeatable
Time frame: 30 minutes
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 16 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitasitiq device in people with No Conditions, run by Vitastiq d.o.o. at 1 site in Slovenia.
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 5 inclusion and 10 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 16 Jan 2018. 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 Slovenia. 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.
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?
Vitastiq device accuracy and performance (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2018.