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

No Conditions Clinical Trial

— VITASTIQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399240
• Other study ID #: Vita-01
• Status: Completed
• Phase: N/A
• First received: January 5, 2018
• Last updated: January 12, 2018
• Start date: May 17, 2017
• Est. completion date: November 2, 2017

Study information

• Verified date: January 2018
• Source: Vitastiq d.o.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• No Conditions

Intervention

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.

Locations

Country	Name	City	State
Slovenia	Adria Lab d.o.o.	Ljubljana

Sponsors (5)

Lead Sponsor	Collaborator
Vitastiq d.o.o.	Adria Lab, Ljubljana, Slovenia, Faculty of Pharmacy, Ljubljana, Slovenia, MEDEDUS, Ljubljana, Slovenia, Vizera d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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