NCT00973583

Brief Summary

The investigators earlier clinical study in 754 young Finnish men demonstrated a significant negative association of serum 25-OHD concentration with acute respiratory tract infections. The present study aimed to determine whether vitamin D supplementation may decrease the incidence of acute respiratory tract infections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 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

May 1, 2005

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

4.6 years

First QC Date

September 8, 2009

Last Update Submit

December 2, 2014

Conditions

Respiratory Tract Infections

Keywords

vitamin DinfectionVitamin D for the prevention of respiratory tract infections

Outcome Measures

Primary Outcomes (1)

  • Number of days absent from duty due to respiratory tract infection

    6 months

Secondary Outcomes (2)

  • The proportion of men remaining healthy throughout the 6-month study period

    6 months

  • The number needed to treat calculated from the proportion of men without any days absent from duty

    6 months

Study Arms (2)

vitamin D

ACTIVE COMPARATOR
Dietary Supplement: vitamin D

placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

vitamin DDIETARY_SUPPLEMENT

vitamin D3 400 IU daily

Also known as: Minisun
vitamin D
placeboDIETARY_SUPPLEMENT

placebo

Also known as: Pharmia, Finland
placebo

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Use vitamin D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university of Tampere

Tampere, 33014, Finland

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsInfections

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ilkka T Laaksi, M.D.

    Tampere University

    PRINCIPAL INVESTIGATOR

  • Harri Pihlajamaki, Docent

    Research Department, Centre for Military Medicine, Helsinki, Finland

    STUDY DIRECTOR

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
M.D. PhD

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

May 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

FI(1)