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

NCT05641818 | Unknown

• 1 other identifier: VITAD-01-2018 Part 3
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D Serum Levels

Outcome Measures

Primary Outcomes (1)

• Difference between vitamin D status (deficiency) assessed by two different methods

  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

Interventions

Screening tool for vitamin D deficiency OTHER

(1) Determination of 25(OH) Vitamin D3 in human serum samples and (2) Question based screening tool with personal (age, gender,...), lifestyle (e.g. sun exposure, outdoor activity) and dietary factors that affect the status of vitamin D in the human body.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• National Institute of Public Health, Slovenia: collaborator
• VIST - Faculty of Applied Sciences: collaborator
• Slovenian Research Agency: collaborator

Study Sites (1)

Nutrition Institute, Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Links

• NUTRI-D project web site

Study Officials

• Igor Pravst, PhD

  Institut za nutricionistiko

  STUDY CHAIR

• Katja Žmitek, PhD

  VIST - Faculty of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: December 5, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

SL (1)