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Completed

NCT Number: NCT03399240

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

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.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adria Lab d.o.o.

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vitastiq d.o.o.

Industry

Collaborators

  • Adria Lab, Ljubljana, Slovenia
  • Faculty of Pharmacy, Ljubljana, Slovenia
  • MEDEDUS, Ljubljana, Slovenia
  • Vizera d.o.o.

Registry information

Acronym: VITASTIQ

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 16, 2018
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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