- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06677411
Vitamin D Status Fluctuations Over One Academic Year in Students
November 5, 2024 updated by: Poznan University of Life Sciences
Annual Fluctuation of Vitamin D Nutritional Status in Students and Its Association with the Occurrence of Inflammation, Depressive States, and Cognitive Abilities
The main objective of the study is to assess changes in the concentration of vitamin D metabolite in serum throughout the academic year and to examine its relationship with the occurrence of inflammation indicators, dietary habits, nutritional status, severity of depressive states, and cognitive abilities in a group of students.
An additional objective will be to assess the relationship between the genotype in the CYP2R1 gene and the concentration of 25(OH) vitamin D.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
70
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
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-
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Poznań, Poland, 60-637
- Poznan University of Life Sciences
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Wielkopolska
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Poznan, Wielkopolska, Poland, 60-637
- Poznan University of Life Sciences
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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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Study population includes students of both sexes at the age of 18-30 years who agree to participate and attend all four study meetings over one academic year.
The participants should be in good health condition.
Description
Inclusion Criteria:
- no chronic diseases
- student status
- age 18-30 years
Exclusion Criteria:
- chronic diseases (related to malabsorption, kidney and liver diseases)
- not active student status
- age <18 and >30 years
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
University students
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It is an observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vitamin D concentration
Time Frame: 01.10.2024-01.10.2025
|
Measurement of 25(OH) vitamin D in serum at four points over an academic year
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01.10.2024-01.10.2025
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammation status measured with CRP
Time Frame: 01.10.2024-01.10.2025
|
01.10.2024-01.10.2025
|
|
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Depressive symptoms
Time Frame: 01.10.2024-01.10.2025
|
The magnitude of depressive symptoms over an academic year
|
01.10.2024-01.10.2025
|
|
Cognitive functions
Time Frame: 01.10.2024-01.10.2025
|
01.10.2024-01.10.2025
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|
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Body composition
Time Frame: 01.10.2024-01.10.2025
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01.10.2024-01.10.2025
|
|
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Dietary intake of vitamin D
Time Frame: 01.10.2024-01.10.2025
|
01.10.2024-01.10.2025
|
|
|
CYP2R1 genotype
Time Frame: 01.10.2024-01.10.2025
|
01.10.2024-01.10.2025
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Emilia Zawieja, PhD, Poznan University of Life Sciences
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)
October 1, 2024
Primary Completion (Estimated)
July 31, 2025
Study Completion (Estimated)
August 31, 2025
Study Registration Dates
First Submitted
September 3, 2024
First Submitted That Met QC Criteria
November 5, 2024
First Posted (Actual)
November 6, 2024
Study Record Updates
Last Update Posted (Actual)
November 6, 2024
Last Update Submitted That Met QC Criteria
November 5, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VITDstud
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.