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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01215682
Other study ID # SHEBA-10-7762-GDR-CTIL
Secondary ID
Status Completed
Phase N/A
First received October 5, 2010
Last updated March 22, 2012
Start date October 2010
Est. completion date March 2011

Study information

Verified date March 2012
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
vitamin D
2000 IU/day of vitamin D3 as a once-daily dose
placebo
sweetened water

Locations

Country Name City State
Israel Maccabi Haifa Swimming Club Haifa
Israel Bnei Herzlyia Swimming Club Herzlyia
Israel Hod Hasharon Swimming Club Hod Hasharon
Israel Maccabim-Reut Swimming Club Maccabim

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary URI frequency 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 No
Primary URI duration 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 No
Primary UTI severity 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 No
Secondary plasma vitamin D levels 3 months No
Secondary immune system function 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 No
Secondary physical function absence from school or training, land and swimming fitness tests. Comparison will be made with changes in vitamin D levels. 3 months No
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