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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399240
Recruitment Status : Completed
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
MEDEDUS, Ljubljana, Slovenia
Adria Lab, Ljubljana, Slovenia
Vizera d.o.o.
Faculty of Pharmacy, Ljubljana, Slovenia
Information provided by (Responsible Party):
Vitastiq d.o.o.

Tracking Information
First Submitted Date  ICMJE January 5, 2018
First Posted Date  ICMJE January 16, 2018
Last Update Posted Date January 16, 2018
Actual Study Start Date  ICMJE May 17, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
Official Title  ICMJE Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE No Conditions
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Vitastiq device
Vitastiq device is used for about 2 months to perform Vitastiq readings every day, preferably in the morning.
Intervention: Device: Vitasitiq device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2018)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03399240
Other Study ID Numbers  ICMJE Vita-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Vitastiq d.o.o.
Study Sponsor  ICMJE Vitastiq d.o.o.
Collaborators  ICMJE
  • MEDEDUS, Ljubljana, Slovenia
  • Adria Lab, Ljubljana, Slovenia
  • Vizera d.o.o.
  • Faculty of Pharmacy, Ljubljana, Slovenia
Investigators  ICMJE Not Provided
PRS Account Vitastiq d.o.o.
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP