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
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Haifa, Israël
- Maccabi Haifa Swimming Club
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Herzlyia, Israël
- Bnei Herzlyia Swimming Club
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Hod Hasharon, Israël
- Hod Hasharon Swimming Club
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Maccabim, Israël
- Maccabim-Reut Swimming Club
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- members of swimming team
- training at least 15 hours/week
- low vitamin D plasma levels (<30 ng/ml)
- signed consent forms
Exclusion Criteria:
- chronic health conditions
- taking prescription medications
- taking diet supplementations
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: placebo
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sweetened water
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Actieve vergelijker: vit D
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2000 IU/day of vitamin D3 as a once-daily dose
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
URI frequency
Tijdsspanne: 3 months
|
URI frequency will be measured in both groups, starting 4 weeks after initiating the suplementation.
Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
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3 months
|
|
URI duration
Tijdsspanne: 3 months
|
URI duration will be measured in both groups, starting 4 weeks after initiating the suplementation.
Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
|
3 months
|
|
UTI severity
Tijdsspanne: 3 months
|
URI severity will be measured in both groups, starting 4 weeks after initiating the suplementation.
Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
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3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
plasma vitamin D levels
Tijdsspanne: 3 months
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3 months
|
|
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immune system function
Tijdsspanne: 3 months
|
T-cell receptor excision circles (TREC), T cell receptor repertoire, B-cell receptor excision circles (BREC).
Comparison will be made with changes in vitamin D levels and with URI characteristics.
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3 months
|
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physical function
Tijdsspanne: 3 months
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absence from school or training, land and swimming fitness tests.
Comparison will be made with changes in vitamin D levels.
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3 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gal Dubnov-Raz, MD MSc, Sheba medical center
- Hoofdonderzoeker: Naama W Constantini, MD, Hadassah Medical Organziation
- Hoofdonderzoeker: Avner Cohen, MD, Clalit Health Services
- Hoofdonderzoeker: Raz Somech, MD PhD, Sheba medical center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SHEBA-10-7762-GDR-CTIL
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