NCT03623763

Brief Summary

The purpose of the study is to determine vitamin D (VD) levels and upper respiratory tract infections (URTI) morbidity among elite athletes engaged in water sports in Uzbekistan. Serum levels of 25(OH) VD and TNF-α, IFN-γ, IL-4 and IL-6 will be detected by ELISA technique among elite athletes and control population in spring and autumn.

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

9 years

First QC Date

July 29, 2018

Last Update Submit

March 1, 2023

Conditions

Keywords

vitamin Dwater sportIL-4IL-6TNF-aIFN-gammaathletesrespiratory infection

Outcome Measures

Primary Outcomes (3)

  • Vitamin D level in elite athletes

    In this study we expect to determine of serum level of vitamin D in elite athletes of Uzbekistan

    up to 36 months

  • Correlation between cytokine status (TNF-α, IFN-γ, IL-4 and IL-6 ) and vitamin D level among elite athletes

    In this study we expect to find association between cytokine status and vitamin D level in elite athletes.

    up to 36 months

  • Incidence of upper respiratory infection among elite athletes with vitamin D deficiency/insufficiency/sufficiency

    In this study we expect to find a role of vitamin D in development of upper respiratory infection among elite athletes.

    up to 36 months

Study Arms (3)

Healthy individuals

Individuals without any complaints and chronic diseases

Diagnostic Test: Serologic tests of blood samples

Swimmers

Elite athletes - swimmers to distance of national team of Uzbekistan

Diagnostic Test: Serologic tests of blood samples

Synchronized swimmers

Elite athletes - swimmers of national team of Uzbekistan

Diagnostic Test: Serologic tests of blood samples

Interventions

Five milliliters of peripheral venous blood will be (after 8-12 hours of fasting) from each participant and will be collected into Human Tube Serum Gel - C/A for ELISA. All blood samples will be collected in August and January. Serum levels of 25(OH) VD and TNF-α, IFN-γ, IL-4 and IL-6 will be detected by ELISA technique

Healthy individualsSwimmersSynchronized swimmers

Eligibility Criteria

Age17 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy individuals Swimmers to distance Synchronized swimmers

You may qualify if:

  • Healthy individuals
  • Swimmers to distance
  • Synchronized swimmers

You may not qualify if:

  • chronic infectious and noninfectious diseases
  • acute infectious and noninfectious diseases
  • history of using VD supplements within six months or drugs usage within three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Umarov J, Kerimov F, Toychiev A, Davis N, Osipova S. Association of the 25(OH) vitamin D status with upper respiratory tract infections morbidity in water sports elite athletes. J Sports Med Phys Fitness. 2019 Dec;59(12):2058-2065. doi: 10.23736/S0022-4707.19.09834-7. Epub 2019 May 2.

Related Links

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

July 29, 2018

First Posted

August 9, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

March 2, 2023

Record last verified: 2023-03