Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections

Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973583
• Other study ID #: UTampere-RO5125
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: December 2, 2014
• Start date: May 2005
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Exclusion Criteria:

• Use vitamin D

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
Finland	university of Tampere	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
University of Tampere	Finnish Defense Forces

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days absent from duty due to respiratory tract infection		6 months	No
Secondary	The proportion of men remaining healthy throughout the 6-month study period		6 months	No
Secondary	The number needed to treat calculated from the proportion of men without any days absent from duty		6 months	No