Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infections

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Tampere.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00973583
First received: September 8, 2009
Last updated: September 10, 2009
Last verified: September 2009
  Purpose

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 Intervention
Respiratory Tract Infections
Dietary Supplement: vitamin D
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Number of days absent from duty due to respiratory tract infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 164
Study Start Date: May 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamin D Dietary Supplement: vitamin D
vitamin D3 400 IU daily
Other Name: Minisun
Placebo Comparator: placebo Dietary Supplement: placebo
placebo
Other Name: Pharmia, Finland

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Use vitamin D
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00973583

Locations
Finland
university of Tampere
Tampere, Finland, 33014
Sponsors and Collaborators
University of Tampere
Investigators
Principal Investigator: Ilkka T Laaksi, M.D. University of Tampere
Study Director: Harri Pihlajamaki, Docent Research Department, Centre for Military Medicine, Helsinki, Finland
  More Information

No publications provided

Responsible Party: M.D. Ilkka Laaksi, University of Tampere, Finland
ClinicalTrials.gov Identifier: NCT00973583     History of Changes
Other Study ID Numbers: UTampere-RO5125
Study First Received: September 8, 2009
Last Updated: September 10, 2009
Health Authority: Finland: Ethics Committee

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

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 20, 2014