Back to resultsVitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections
Primary Purpose
Respiratory Tract Infections
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
vitamin D
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Tract Infections focused on measuring vitamin D, infection, Vitamin D for the prevention of respiratory tract infections
Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
- Use vitamin D
Sites / Locations
- university of Tampere
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
vitamin D
placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of days absent from duty due to respiratory tract infection
Secondary Outcome Measures
The proportion of men remaining healthy throughout the 6-month study period
The number needed to treat calculated from the proportion of men without any days absent from duty
Full Information
NCT ID
NCT00973583
First Posted
September 8, 2009
Last Updated
December 2, 2014
Sponsor
Tampere University
Collaborators
Finnish Defense Forces
1. Study Identification
Unique Protocol Identification Number
NCT00973583
Brief Title
Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections
Official Title
Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections; a Randomized Double-blinded Trial in Young Finnish Men
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Finnish Defense Forces
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections
Keywords
vitamin D, infection, Vitamin D for the prevention of respiratory tract infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin D
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Other Intervention Name(s)
Minisun
Intervention Description
vitamin D3 400 IU daily
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Other Intervention Name(s)
Pharmia, Finland
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Number of days absent from duty due to respiratory tract infection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The proportion of men remaining healthy throughout the 6-month study period
Time Frame
6 months
Title
The number needed to treat calculated from the proportion of men without any days absent from duty
Time Frame
6 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Exclusion Criteria:
Use vitamin D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilkka T Laaksi, M.D.
Organizational Affiliation
Tampere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harri Pihlajamaki, Docent
Organizational Affiliation
Research Department, Centre for Military Medicine, Helsinki, Finland
Official's Role
Study Director
Facility Information:
Facility Name
university of Tampere
City
Tampere
ZIP/Postal Code
33014
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections
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