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Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections

This study has been completed.
Sponsor:
Collaborator:
Finnish Defense Forces
Information provided by (Responsible Party):
Ilkka Laaksi, University of Tampere
ClinicalTrials.gov Identifier:
NCT00973583
First received: September 8, 2009
Last updated: December 2, 2014
Last verified: December 2014

September 8, 2009
December 2, 2014
May 2005
December 2009   (final data collection date for primary outcome measure)
Number of days absent from duty due to respiratory tract infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00973583 on ClinicalTrials.gov Archive Site
  • The proportion of men remaining healthy throughout the 6-month study period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The number needed to treat calculated from the proportion of men without any days absent from duty [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Respiratory Tract Infections
  • Dietary Supplement: vitamin D
    vitamin D3 400 IU daily
    Other Name: Minisun
  • Dietary Supplement: placebo
    placebo
    Other Name: Pharmia, Finland
  • Active Comparator: vitamin D
    Intervention: Dietary Supplement: vitamin D
  • Placebo Comparator: placebo
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
164
December 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Exclusion Criteria:

  • Use vitamin D
Male
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00973583
UTampere-RO5125
No
Ilkka Laaksi, University of Tampere
University of Tampere
Finnish Defense Forces
Principal Investigator: Ilkka T Laaksi, M.D. University of Tampere
Study Director: Harri Pihlajamaki, Docent Research Department, Centre for Military Medicine, Helsinki, Finland
University of Tampere
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP