AthletesNCT03623763
Vitamin D Level Among Athletes in Uzbekistan
An observational study of Athletes and Respiratory Infection, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes, Respiratory Infection, Cytokines
- What is being tested?
- Serologic tests of blood samples
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Apr 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy individuals Swimmers to distance Synchronized swimmers
Who may be able to join
- Healthy individuals
- Swimmers to distance
- Synchronized swimmers
Who cannot join
- chronic infectious and noninfectious diseases
- acute infectious and noninfectious diseases
- history of using VD supplements within six months or drugs usage within three months.
About this study
Official title: Vitamin D Level Among Water Sports Elite Athletes in Uzbekistan
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).
- Conditions
- Athletes, Respiratory Infection, Cytokines, Vitamin D
- Being tested
- Serologic tests of blood samples
- Keywords
- vitamin D, water sport, IL-4, IL-6, TNF-a, IFN-gamma, athletes, respiratory infection
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serologic tests of blood samplesDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Individuals without any complaints and chronic diseases Receives: Diagnostic Test: Serologic tests of blood samples | |
| Swimmers | Elite athletes - swimmers to distance of national team of Uzbekistan Receives: Diagnostic Test: Serologic tests of blood samples | |
| Synchronized swimmers | Elite athletes - swimmers of national team of Uzbekistan Receives: Diagnostic Test: Serologic tests of blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level in elite athletes
In this study we expect to determine of serum level of vitamin D in elite athletes of Uzbekistan
Measured: 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.
Measured: 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.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jan 2017
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Why it stopped: Financial difficulities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623763
- Sponsor's protocol ID
- #30072018
- Status last verified
- Mar 2023
- First submitted
- 29 Jul 2018
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Level Among Water Sports Elite Athletes in Uzbekistan
- ClinicalTrials.gov ID
- NCT03623763
- Acronym / sponsor ID
- #30072018
- Conditions
- Athletes, Respiratory Infection, Cytokines, Vitamin D
- Keywords
- vitamin D, water sport, IL-4, IL-6, TNF-a, IFN-gamma, athletes, respiratory infection
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Financial difficulities
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, UzbekistanOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Diagnostic Test: Serologic tests of blood samplesIndividuals without any complaints and chronic diseases |
| Swimmers | – | Diagnostic Test: Serologic tests of blood samplesElite athletes - swimmers to distance of national team of Uzbekistan |
| Synchronized swimmers | – | Diagnostic Test: Serologic tests of blood samplesElite athletes - swimmers of national team of Uzbekistan |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy individuals Swimmers to distance Synchronized swimmers
Key inclusion criteria (3 listed)
- Healthy individuals
- Swimmers to distance
- Synchronized swimmers
Key exclusion criteria (3 listed)
- chronic infectious and noninfectious diseases
- acute infectious and noninfectious diseases
- history of using VD supplements within six months or drugs usage within three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serologic tests of blood samplesFive 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 | Diagnostic test | Healthy individuals, Swimmers, Synchronized swimmers |
Primary outcome
Vitamin D level in elite athletes
Time frame: up to 36 months
In this study we expect to determine of serum level of vitamin D in elite athletes of Uzbekistan
Correlation between cytokine status (TNF-α, IFN-γ, IL-4 and IL-6 ) and vitamin D level among elite athletes
Time frame: up to 36 months
In this study we expect to find association between cytokine status and vitamin D level in elite athletes.
Incidence of upper respiratory infection among elite athletes with vitamin D deficiency/insufficiency/sufficiency
Time frame: up to 36 months
In this study we expect to find a role of vitamin D in development of upper respiratory infection among elite athletes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Results publication: PubMed 31062952Umarov 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletes and Respiratory Infection, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D level in elite athletes (time frame: up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.