Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENTvitamin D2000 IU/day of vitamin D3 as a once-daily dose
DIETARY_SUPPLEMENTplacebosweetened 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.