Status:
COMPLETED
Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
Lead Sponsor:
Vitastiq d.o.o.
Collaborating Sponsors:
MEDEDUS, Ljubljana, Slovenia
Adria Lab, Ljubljana, Slovenia
Conditions:
No Conditions
Eligibility:
All Genders
18-64 years
Phase:
NA
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03399240
Start Date
May 17 2017
End Date
November 2 2017
Last Update
January 16 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Adria Lab d.o.o.
Ljubljana, Slovenia, 1000