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

Vitastiq

Status: Completed

Conditions: No Conditions

Treatments: Device: Vitasitiq device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03399240

Vita-01

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Vitastiq device

Experimental group

Description:

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

Treatment:

Device: Vitasitiq device