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Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections

NCT ID: NCT00973583

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Subjects comprised 164 male conscripts at a military base in Finland. Half of the participants were randomly allocated to receive 400 IU vitamin D daily and half received placebo from October through March. Serum vitamin D and plasma parathyroid hormone concentrations were determined. Subjects were followed for 6 months and the primary outcome was the number of days absent from duty due to ARTI.

Conditions

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Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vitamin D

Group Type ACTIVE_COMPARATOR

vitamin D

Intervention Type DIETARY_SUPPLEMENT

vitamin D3 400 IU daily

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

placebo

Interventions

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vitamin D

vitamin D3 400 IU daily

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Minisun Pharmia, Finland

Eligibility Criteria

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Exclusion Criteria

* Use vitamin D
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Finnish Defense Forces

OTHER_GOV

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role lead

Responsible Party

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Ilkka Laaksi

M.D. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilkka T Laaksi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tampere University

Harri Pihlajamaki, Docent

Role: STUDY_DIRECTOR

Research Department, Centre for Military Medicine, Helsinki, Finland

Locations

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university of Tampere

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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UTampere-RO5125

Identifier Type: -

Identifier Source: org_study_id