Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers
Primary Purpose
Upper Respiratory Tract Infections
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
vitamin D
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Tract Infections focused on measuring infections, immune system, vitamin D, sport, children
Eligibility Criteria
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
Sites / Locations
- Maccabi Haifa Swimming Club
- Bnei Herzlyia Swimming Club
- Hod Hasharon Swimming Club
- Maccabim-Reut Swimming Club
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
vit D
placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
plasma vitamin D levels
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.
physical function
absence from school or training, land and swimming fitness tests. Comparison will be made with changes in vitamin D levels.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01215682
Brief Title
Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers
Official Title
Vitamin D Supplementation, Upper Respiratory Tract Infections, Immune and Physical Functions in Adolescent Swimmers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
Keywords
infections, immune system, vitamin D, sport, children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vit D
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
2000 IU/day of vitamin D3 as a once-daily dose
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
sweetened water
Primary Outcome Measure Information:
Title
URI frequency
Description
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.
Time Frame
3 months
Title
URI duration
Description
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.
Time Frame
3 months
Title
UTI severity
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
plasma vitamin D levels
Time Frame
3 months
Title
immune system function
Description
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.
Time Frame
3 months
Title
physical function
Description
absence from school or training, land and swimming fitness tests. Comparison will be made with changes in vitamin D levels.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gal Dubnov-Raz, MD MSc
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naama W Constantini, MD
Organizational Affiliation
Hadassah Medical Organziation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Avner Cohen, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raz Somech, MD PhD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maccabi Haifa Swimming Club
City
Haifa
Country
Israel
Facility Name
Bnei Herzlyia Swimming Club
City
Herzlyia
Country
Israel
Facility Name
Hod Hasharon Swimming Club
City
Hod Hasharon
Country
Israel
Facility Name
Maccabim-Reut Swimming Club
City
Maccabim
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
25050610
Citation
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.
Results Reference
derived
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Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers
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