Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections

Verified by: University of Tampere, September 2009
First Received: September 8, 2009 | Last Updated: September 10, 2009 | Phase: N/A | Start Date: May 2005
Overall Status: Active, not recruiting | Estimated Enrollment: 164
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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...

Brief Summary

Official Title: “Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections; a Randomized Double-blinded Trial in Young Finnish Men”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
  • Study Primary Completion Date: December 2009

Detailed Clinical Trial Description

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.

Intervention(s) in this Clinical Trial

  • Dietary Supplement: vitamin D
    • vitamin D3 400 IU daily
  • Dietary Supplement: placebo
    • placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: vitamin D
  • Placebo Comparator: placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Number of days absent from duty due to respiratory tract infection
    • Time Frame: 6 months
      Safety Issue?: No

Secondary Measures

  • The proportion of men remaining healthy throughout the 6-month study period
    • Time Frame: 6 months
      Safety Issue?: No
  • The number needed to treat calculated from the proportion of men without any days absent from duty
    • Time Frame: 6 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

Exclusion Criteria:

  • Use vitamin D

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: University of Tampere Other

Overall Clinical Trial Officials and Contacts

Ilkka T Laaksi, M.D. Principal Investigator University of Tampere  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00973583

Study ID Number: UTampere-RO5125

ClinicalTrials.gov Identifier: NCT00973583

Health Authority: Finland: Ethics Committee

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00973583