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

First Received on September 8, 2009. Last Updated on September 10, 2009 History of Changes

Sponsor:	University of Tampere
Information provided by:	University of Tampere
ClinicalTrials.gov Identifier:	NCT00973583

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:

MedlinePlus related topics: Vitamin D

U.S. FDA Resources

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

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 May 24, 2012