Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers
NCT ID: NCT01215682
Last Updated: 2012-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2010-10-31
2011-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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vit D
vitamin D
2000 IU/day of vitamin D3 as a once-daily dose
placebo
placebo
sweetened water
Interventions
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vitamin D
2000 IU/day of vitamin D3 as a once-daily dose
placebo
sweetened water
Eligibility Criteria
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Inclusion Criteria
* training at least 15 hours/week
* low vitamin D plasma levels (\<30 ng/ml)
* signed consent forms
Exclusion Criteria
* taking prescription medications
* taking diet supplementations
12 Years
18 Years
ALL
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Gal Raz-Dubnov MD, MSc
senior physician
Principal Investigators
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Gal Dubnov-Raz, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Naama W Constantini, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organziation
Avner Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Clalit Health Services
Raz Somech, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Maccabi Haifa Swimming Club
Haifa, , Israel
Bnei Herzlyia Swimming Club
Herzlyia, , Israel
Hod Hasharon Swimming Club
Hod HaSharon, , Israel
Maccabim-Reut Swimming Club
Maccabim, , Israel
Countries
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References
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Dubnov-Raz G, Rinat B, Hemila H, Choleva L, Cohen AH, Constantini NW. Vitamin D supplementation and upper respiratory tract infections in adolescent swimmers: a randomized controlled trial. Pediatr Exerc Sci. 2015 Feb;27(1):113-9. doi: 10.1123/pes.2014-0030. Epub 2014 Jul 15.
Other Identifiers
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SHEBA-10-7762-GDR-CTIL
Identifier Type: -
Identifier Source: org_study_id
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