Vitamin D Status Fluctuations Over One Academic Year in S... | NCT06677411

Studies
Vitamin D Status Fluctuations Over One Academic Year in Students

NCT06677411

Sponsor

Poznan University of Life Sciences

Status

Unknown status

Last Update Posted

Nov 6, 2024Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Vitamin D Deficiency

Interventions

Observention of vitamin D

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Actual

Primary Completion Date

Jul 31, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Sep 3, 2024

First Submission Date that Met QC Criteria

Nov 5, 2024

First Posted Date

Nov 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2024

Last Update Posted Date

Nov 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
University students			Other: Observention of vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observention of vitamin D	Other	It is an observational study	University students

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vitamin D concentration	Measurement of 25(OH) vitamin D in serum at four points over an academic year	01.10.2024-01.10.2025

Secondary Outcomes

Measure	Description	Time Frame
Inflammation status measured with CRP		01.10.2024-01.10.2025
Depressive symptoms	The magnitude of depressive symptoms over an academic year	01.10.2024-01.10.2025

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emilia Zawieja, PhD	Poznan University of Life Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Poznan University of Life Sciences		Poznan	Wielkopolska	60-637	Poland
Poznan University of Life Sciences

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41689927	Derived	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.

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders