Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973583
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : December 3, 2014
Finnish Defense Forces
Information provided by (Responsible Party):
Ilkka Laaksi, University of Tampere

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.

Condition or disease Intervention/treatment
Respiratory Tract Infections Dietary Supplement: vitamin D Dietary Supplement: placebo

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  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections; a Randomized Double-blinded Trial in Young Finnish Men
Study Start Date : May 2005
Primary Completion Date : December 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: vitamin D Dietary Supplement: vitamin D
vitamin D3 400 IU daily
Other Name: Minisun
Placebo Comparator: placebo Dietary Supplement: placebo
Other Name: Pharmia, Finland

Primary Outcome Measures :
  1. Number of days absent from duty due to respiratory tract infection [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The proportion of men remaining healthy throughout the 6-month study period [ Time Frame: 6 months ]
  2. The number needed to treat calculated from the proportion of men without any days absent from duty [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Exclusion Criteria:

  • Use vitamin D

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973583

university of Tampere
Tampere, Finland, 33014
Sponsors and Collaborators
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

Responsible Party: Ilkka Laaksi, M.D. PhD, University of Tampere Identifier: NCT00973583     History of Changes
Other Study ID Numbers: UTampere-RO5125
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Ilkka Laaksi, University of Tampere:
vitamin D
Vitamin D for the prevention of respiratory tract infections

Additional relevant MeSH terms:
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents