Vitamin D DeficiencyNCT06677411
Vitamin D Status Fluctuations Over One Academic Year in Students
An observational study of Vitamin D Deficiency, run by Poznan University of Life Sciences at 2 sites in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Observention of vitamin D
- How many people
- 70 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Oct 2024to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- no chronic diseases
- student status
- age 18-30 years
Who cannot join
- chronic diseases (related to malabsorption, kidney and liver diseases)
- not active student status
- age <18 and >30 years
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Poznan University of Life Sciences
Poznan, Wielkopolska, 60-637
Poznan University of Life Sciences
Poznan, 60-637
About this study
Official title: 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Observention of vitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observention of vitamin DOther
It is an observational study
| Study group | Role | What they receive |
|---|---|---|
| University students | Not described Receives: Other: Observention of vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D concentration
Measurement of 25(OH) vitamin D in serum at four points over an academic year
Measured: 01.10.2024-01.10.2025
Secondary outcomes (6)
Inflammation status measured with CRP
Measured: 01.10.2024-01.10.2025
Depressive symptoms
The magnitude of depressive symptoms over an academic year
Measured: 01.10.2024-01.10.2025
Cognitive functions
Measured: 01.10.2024-01.10.2025
Body composition
Measured: 01.10.2024-01.10.2025
Dietary intake of vitamin D
Measured: 01.10.2024-01.10.2025
CYP2R1 genotype
Measured: 01.10.2024-01.10.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Oct 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilia Zawieja, PhD, Principal investigator, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677411
- Sponsor's protocol ID
- VITDstud
- Status last verified
- Jun 2024
- First submitted
- 3 Sep 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zawieja E, Bykowska-Derda A, Chmurzynska A. Yearlong fluctuations of vitamin D status, intake, and health outcomes in university students: A prospective longitudinal study. Nutrition. 2026 Jun;146:113111. doi: 10.1016/j.nut.2026.113111. Epub 2026 Jan 15.
PubMed 41689927
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Annual Fluctuation of Vitamin D Nutritional Status in Students and Its Association with the Occurrence of Inflammation, Depressive States, and Cognitive Abilities
- ClinicalTrials.gov ID
- NCT06677411
- Acronym / sponsor ID
- VITDstud
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| University students | – | Other: Observention of vitamin D |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- no chronic diseases
- student status
- age 18-30 years
Key exclusion criteria (3 listed)
- chronic diseases (related to malabsorption, kidney and liver diseases)
- not active student status
- age <18 and >30 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observention of vitamin DIt is an observational study | Other | University students |
Primary outcome
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
6 secondary outcomes
Inflammation status measured with CRP
Time frame: 01.10.2024-01.10.2025
Depressive symptoms
Time frame: 01.10.2024-01.10.2025
Cognitive functions
Time frame: 01.10.2024-01.10.2025
Body composition
Time frame: 01.10.2024-01.10.2025
Dietary intake of vitamin D
Time frame: 01.10.2024-01.10.2025
CYP2R1 genotype
Time frame: 01.10.2024-01.10.2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Derived from this study: PubMed 41689927Zawieja E, Bykowska-Derda A, Chmurzynska A. Yearlong fluctuations of vitamin D status, intake, and health outcomes in university students: A prospective longitudinal study. Nutrition. 2026 Jun;146:113111. doi: 10.1016/j.nut.2026.113111. Epub 2026 Jan 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Zawieja, PhD principal investigator
Poznan University of Life Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Poznan University of Life Sciences at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D concentration (time frame: 01.10.2024-01.10.2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06677411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.