Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers

NCT01215682 | Completed

• 1 other identifier: SHEBA-10-7762-GDR-CTIL
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

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.

Conditions

Upper Respiratory Tract Infections

Keywords

infections; immune system; vitamin D; sport; children

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (3)

• plasma vitamin D levels

  3 months

• immune system function

  3 months

• physical function

  3 months

Study Arms (2)

vit D

ACTIVE COMPARATOR

Dietary Supplement: vitamin D

placebo

PLACEBO COMPARATOR

Dietary Supplement: placebo

Interventions

vitamin D DIETARY_SUPPLEMENT

2000 IU/day of vitamin D3 as a once-daily dose

vit D

placebo DIETARY_SUPPLEMENT

sweetened water

placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• members of swimming team
• training at least 15 hours/week
• low vitamin D plasma levels (\<30 ng/ml)
• signed consent forms

You may not qualify if:

• chronic health conditions
• taking prescription medications
• taking diet supplementations

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (4)

Maccabi Haifa Swimming Club

Haifa, Israel

Location

Bnei Herzlyia Swimming Club

Herzlyia, Israel

Location

Hod Hasharon Swimming Club

Hod HaSharon, Israel

Location

Maccabim-Reut Swimming Club

Maccabim, Israel

Location

Related Publications (1)

• 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.

  PMID: 25050610 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Infections

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Gal Dubnov-Raz, MD MSc

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Naama W Constantini, MD

  Hadassah Medical Organziation

  PRINCIPAL INVESTIGATOR

• Avner Cohen, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

• Raz Somech, MD PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior physician

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 6, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

IL (4)