Upper Respiratory Tract Infections Clinical Trial
Official title:
Vitamin D Supplementation, Upper Respiratory Tract Infections, Immune and Physical Functions in Adolescent Swimmers
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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