Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3 (VITAD/3)

December 13, 2022 updated by: Nutrition Institute, Slovenia

Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3: Screening Tool for Identification of Subjects at Risk for Suboptimal Vitamin D Status

Validation of a screening tool for identification of subjects at risk for suboptimal vitamin D status. Developed questionnaire-based screening tool will be used on subjects with various risks for vitamin D deficiency, and compared with 25-OH-vitamin D levels.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Nutrition Institute, Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult users and non-users of vitamin D drugs and food supplements living in Slovenia. Participants invited from the database at Nutrition Institute.

Description

Inclusion Criteria:

  • Signed Informed consent form (ICF),
  • Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
  • Did not change use of vitamin D conatining drugs/supplements for last 6 weeks
  • Willingness to follow all study procedures

Exclusion Criteria:

  • Pregnancy or breastfeeding,
  • Change in use of food supplements containing Vitamin D in last 6 weeks
  • Acute ilness
  • Mental incapacity that precludes adequate understanding or cooperation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between vitamin D status (deficiency) assessed by two different methods
Time Frame: 1 year
Vitamin D serum level will be measured for assessment of Vitamin D status. Risk for vitamin D deficiency will be assessed using questionaire-based screening tool. Two methods will be compared.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutrition Institute, Slovenia

Collaborators

National Institute of Public Health, Slovenia
Slovenian Research Agency
Higher School of Applied Sciences (VIST)

Investigators

  • Study Chair: Igor Pravst, PhD, Institut za nutricionistiko
  • Principal Investigator: Katja Žmitek, PhD, Higher School of Applied Sciences (VIST)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

November 29, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITAD-01-2018 Part 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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