NCT06677411

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

November 6, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

September 3, 2024

Last Update Submit

November 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Inflammation status measured with CRP

    01.10.2024-01.10.2025

  • Depressive symptoms

    01.10.2024-01.10.2025

  • Cognitive functions

    01.10.2024-01.10.2025

  • Body composition

    01.10.2024-01.10.2025

  • Dietary intake of vitamin D

    01.10.2024-01.10.2025

  • +1 more secondary outcomes

Study Arms (1)

University students

Other: Observention of vitamin D

Interventions

It is an observational study

University students

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • no chronic diseases
  • student status
  • age 18-30 years

You may not qualify if:

  • chronic diseases (related to malabsorption, kidney and liver diseases)
  • not active student status
  • age \<18 and \>30 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Poznan University of Life Sciences

Poznan, Wielkopolska, 60-637, Poland

Location

Poznan University of Life Sciences

Poznan, 60-637, Poland

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Emilia Zawieja, PhD

    Poznan University of Life Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

November 6, 2024

Study Start

October 1, 2024

Primary Completion

July 31, 2025

Study Completion

August 31, 2025

Last Updated

November 6, 2024

Record last verified: 2024-06

Locations