- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01215682
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Haifa, Israel
- Maccabi Haifa Swimming Club
-
Herzlyia, Israel
- Bnei Herzlyia Swimming Club
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Hod Hasharon, Israel
- Hod Hasharon Swimming Club
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Maccabim, Israel
- Maccabim-Reut Swimming Club
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: placebo
|
sweetened water
|
Aktiv komparator: vit D
|
2000 IU/day of vitamin D3 as a once-daily dose
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
URI frequency
Tidsram: 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.
|
3 months
|
URI duration
Tidsram: 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
Tidsram: 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.
|
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
plasma vitamin D levels
Tidsram: 3 months
|
3 months
|
|
immune system function
Tidsram: 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.
|
3 months
|
physical function
Tidsram: 3 months
|
absence from school or training, land and swimming fitness tests.
Comparison will be made with changes in vitamin D levels.
|
3 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gal Dubnov-Raz, MD MSc, Sheba Medical Center
- Huvudutredare: Naama W Constantini, MD, Hadassah Medical Organziation
- Huvudutredare: Avner Cohen, MD, Clalit Health Services
- Huvudutredare: Raz Somech, MD PhD, Sheba Medical Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SHEBA-10-7762-GDR-CTIL
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