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

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 Overview

• Status: Completed
• Conditions: No Conditions
• Intervention / Treatment: Device: Vitasitiq device

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Adria Lab d.o.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes

Collaborators and Investigators

• Sponsor: Vitastiq d.o.o.
• Collaborators: MEDEDUS, Ljubljana, Slovenia; Adria Lab, Ljubljana, Slovenia; Vizera d.o.o.; Faculty of Pharmacy, Ljubljana, Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): November 2, 2017
• Study Completion (Actual): November 2, 2017

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Vita-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No