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
Recruitment status was Active, not recruiting
Sponsor:
University of Tampere
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00973583
First received: September 8, 2009
Last updated: September 10, 2009
Last verified: September 2009
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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
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 23, 2013