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

Vitamin D Serum Levels Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05641818
• Other study ID #: VITAD-01-2018 Part 3
• Status: Enrolling by invitation
• Start date: December 5, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2022
• Source: Nutrition Institute, Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Serum Levels

Intervention

Other:
• Screening tool for vitamin D deficiency
(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.

Locations

Country	Name	City	State
Slovenia	Nutrition Institute, Ljubljana	Ljubljana

Sponsors (4)

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

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   NUTRI-D project web site