NCT05014048

Brief Summary

Vitamin D intervention effects on the prevention of acute respiratory tract infections among Young Finnish Men

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

December 16, 2020

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Days off duty due to acute respiratory tract infections

    The number of Days off Duty recommended by Health care personnel will be calculated in order to show the severity and last of the disease. By that it could be estimated how the disease will effect on duty service.

    4 months

Secondary Outcomes (2)

  • Days off duty due to musculoskeletal disorders

    4 months

  • Aerobic and muscular fitness

    4 months

Study Arms (2)

vitamin D3

ACTIVE COMPARATOR

20 mikrog vitamin D3 daily, 3 months

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT

20 mikrog vitamin D3 daily

vitamin D3
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • years of age
  • examined as Healthy according to Finnish Military Health Care regulations

You may not qualify if:

  • Female
  • age \> 30 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Defence Forces

Hämeenlinna, 13210, Finland

Location

Related Publications (1)

  • Laaksi A, Kyrolainen H, Pihlajamaki H, Vaara JP, Luukkaala T, Laaksi I. Effects of Vitamin D Supplementation and Baseline Vitamin D Status on Acute Respiratory Infections and Cathelicidin: A Randomized Controlled Trial. Open Forum Infect Dis. 2024 Aug 27;11(9):ofae482. doi: 10.1093/ofid/ofae482. eCollection 2024 Sep.

MeSH Terms

Conditions

Vitamin D DeficiencyRespiratory Tract Infections

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesInfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • ilkka laaksi, MDPhD

    University of Tampere, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2020

First Posted

August 20, 2021

Study Start

January 4, 2018

Primary Completion

May 14, 2018

Study Completion

May 14, 2018

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations