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Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body (VITASTIQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399240
Recruitment Status : Completed
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
MEDEDUS, Ljubljana, Slovenia
Adria Lab, Ljubljana, Slovenia
Vizera d.o.o.
Faculty of Pharmacy, Ljubljana, Slovenia
Information provided by (Responsible Party):
Vitastiq d.o.o.

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
No Conditions Device: Vitasitiq device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : November 2, 2017
Actual Study Completion Date : November 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitastiq device
Vitastiq device is used for about 2 months to perform Vitastiq readings every day, preferably in the morning.
 Device: Vitasitiq device
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Vitastiq readings method is repeatable [ Time Frame: 30 minutes ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399240


Locations
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Slovenia
Adria Lab d.o.o.
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Vitastiq d.o.o.
MEDEDUS, Ljubljana, Slovenia
Adria Lab, Ljubljana, Slovenia
Vizera d.o.o.
Faculty of Pharmacy, Ljubljana, Slovenia
  Study Documents (Full-Text)

Documents provided by Vitastiq d.o.o.:
Study Protocol and Statistical Analysis Plan  [PDF] May 3, 2017

More Information
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Responsible Party: Vitastiq d.o.o.
ClinicalTrials.gov Identifier: NCT03399240    
Other Study ID Numbers: Vita-01
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No