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

NCT03399240 | Completed

• 1 other identifier: Vita-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

No Conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Vitastiq readings method is repeatable

  30 minutes

Study Arms (1)

Vitastiq device

EXPERIMENTAL

Vitastiq device is used for about 2 months to perform Vitastiq readings every day, preferably in the morning.

Device: Vitasitiq device

Interventions

Vitasitiq device 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.

Vitastiq device

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Willing to follow all study procedures, including attending all site visits, and keeping a food diary and diary of activities on a weekly basis

You may not qualify if:

• 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

Sponsors & Collaborators

• Vitastiq d.o.o.: lead
• MEDEDUS, Ljubljana, Slovenia: collaborator
• Adria Lab, Ljubljana, Slovenia: collaborator
• Vizera d.o.o.: collaborator
• Faculty of Pharmacy, Ljubljana, Slovenia: collaborator

Study Sites (1)

Adria Lab d.o.o.

Ljubljana, 1000, Slovenia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 16, 2018
• Study Start: May 17, 2017
• Primary Completion: November 2, 2017
• Study Completion: November 2, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

SL (1)