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SuspendedNCT03623763Updated Mar 2, 2023

Vitamin D Level Among Athletes in Uzbekistan

An observational study in Athletes, Respiratory Infection and Cytokines, sponsored by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan. Suspended. Open to participants aged 17 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan · Observational

Why this study was suspended
Financial difficulities
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
17 Years to 28 Years
Sex
All
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Study 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.

Read the detailed description

Study center The prospective diagnostic study will be conducted on the basis of Uzbek State University of Physical Education and Sport and Research Institute of Epidemiology, Microbiology and Infectious Diseases, Tashkent, Uzbekistan during the period from January 2017 till January 2019.

Both informed and written consents will be obtained from the athletes and healthy individuals.

Study participants Aproximately 40 elite athletes engaged in water sport and 60 healthy individuals will be included to the study.

All the participants will be residents of Uzbekistan.

Serological tests Five milliliters of peripheral venous blood will be taken (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.

Enzyme immunoassay for the quantitative measurement of total 25-OH-Vitamin D (Vitamin D2 and D3) in human serum.

Solid phase enzyme-linked immunosorbent assay (ELISA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labelled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After the substrate reaction the intensity of the developed colour is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

A sandwich enzyme immunoassay for in vitro quantitative measurement of TNFa The microplate provided in this kit has been pre-coated with an antibody specific to TNFa. Standards or samples are then added to the appropriate microplate wells with a biotin-conjugated antibody specific to TNFa. Next, Avidin conjugated to Horseradish Peroxidase (HRP) is added to each microplate well and incubated. After TMB substrate solution is added, only those wells that contain TNFa, biotin-conjugated antibody and enzyme-conjugated Avidin will exhibit a change in color. The enzyme-substrate reaction is terminated by the addition of sulphuric acid solution and the color change is measured spectrophotometrically at a wavelength of 450nm ± 10nm. The concentration of TNFa in the samples is then determined by comparing the O.D. of the samples to the standard curve.

IFN-γ, IL-4 and IL-6 will be detected and measured by the same enzyme immunoassay method presented above.

Data analysis will be performed with the program Origin 6.1 (OriginLab, Northampton, MA).

02

Conditions studied

  • Athletes
  • Respiratory Infection
  • Cytokines
  • Vitamin D

Keywords

  • vitamin D
  • water sport
  • IL-4
  • IL-6
  • TNF-a
  • IFN-gamma
  • athletes
  • respiratory infection
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In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's enrollment of 100 is below the median of 300 across 295 observational studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 28 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy individuals Swimmers to distance Synchronized swimmers

Inclusion criteria

  • Healthy individuals
  • Swimmers to distance
  • Synchronized swimmers

Exclusion criteria

Exclusion Criteria:

  • chronic infectious and noninfectious diseases
  • acute infectious and noninfectious diseases
  • history of using VD supplements within six months or drugs usage within three months.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testSerologic tests of blood samples

    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

06

What researchers measure

Primary outcomes

  1. Vitamin D level in elite athletes

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

    Time frame: up to 36 months

  2. 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.

    Time frame: up to 36 months

  3. 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.

    Time frame: up to 36 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 31062952 ↗

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03623763
Lead sponsor
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
Responsible party
Svetlana Osipova, MD, PhD, DS (Senior researcher, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan) — Principal investigator
First posted
Aug 9, 2018
Start date
Jan 1, 2017
Primary completion
Jan 1, 2026 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Mar 2, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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