Trials / Completed
CompletedNCT01215682
Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers
Vitamin D Supplementation, Upper Respiratory Tract Infections, Immune and Physical Functions in Adolescent Swimmers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Sheba Medical Center · Other Government
- Sex
- All
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Accepted
Summary
Background: The medical and economic burden of upper respiratory tract infections (URTIs) is extremely high, while prevention and treatment options are limited. Therefore, there is a constant need for new methods in order to significantly decrease such morbidity. Extensive evidence shows that vitamin D is associated with respiratory health, including in the prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and can serve as a model for research in this field. The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D levels will reduce the frequency, length, and severity of URTIs and their accompanying functional impairment, while improving cellular immune function and physical function. Methods: After screening 100 competitive adolescent swimmers to obtain \~60 with low serum levels of vitamin D, this study group will be randomized to receive either vitamin D supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months. Participants will fill a daily questionnaire regarding frequency, length and severity of URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin D status (25(OH)D) and immune function among study participants at the beginning of the study and after supplementation. Physical function on land and in water will also be assessed. Expected results: Increase in serum 25(OH)D levels following supplementation will significantly decrease the frequency, length and severity of URTI's and their functional impairment, while enhancing the cellular immune system function and physical capacity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | vitamin D | 2000 IU/day of vitamin D3 as a once-daily dose |
| DIETARY_SUPPLEMENT | placebo | sweetened water |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2011-03-01
- Completion
- 2011-03-01
- First posted
- 2010-10-06
- Last updated
- 2012-03-26
Locations
4 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT01215682. Inclusion in this directory is not an endorsement.