Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections

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 Overview

• Status: Completed
• Conditions: Respiratory Tract Infections
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: vitamin D

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33014
    • University of Tampere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

Exclusion Criteria:

• Use vitamin D

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Dietary supplement: placebo; placebo; Other Names: Pharmia, Finland
Active Comparator: vitamin D	Dietary supplement: vitamin D; vitamin D3 400 IU daily; Other Names: Minisun

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of days absent from duty due to respiratory tract infection	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tampere University
• Collaborators: Finnish Defense Forces
• Investigators: Principal Investigator: Ilkka T Laaksi, M.D., Tampere University; Study Director: Harri Pihlajamaki, Docent, Research Department, Centre for Military Medicine, Helsinki, Finland

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 8, 2009
• First Submitted That Met QC Criteria: September 8, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: infection; vitamin D; Vitamin D for the prevention of respiratory tract infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: UTampere-RO5125