- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03584256
Vitamin D Status Among Competitive Female Gymnast and Swimmers After Winter Time
Vitamin D Status Relate to Bone Mineral Density, Body Composition and Variey Cardiovascular Risk Factors Among Competitive Female Gymnasts and Swimmers After Winter Time
Study Overview
Status
Detailed Description
In this cross-sectional survey, the investigators will document vitamin D and the status of other micronutrients related to bone mineral density, body composition and a variety of risk factors for chronic non-communicable diseases.
The investigators hypothesize that there exists a serious problem of vitamin D deficiency among indoor athletes related to bone health, injuries and general health - especially when they are not using supplements. It is well known that vitamin D may improve athletic performance in vitamin D-deficient athletes.
International and national-level female gymnasts and swimmers that will be enrolled will sign an informed consent statement for the inclusion in this survey and the choice to participate in the study will be made by coaches and participants themselves and, in the event of females under 18 years of age, also by their parents, in accordance with the Helsinki declaration.
The investigators plan to enroll at least 30 female participants (15 gymnasts and 15 swimmers) who compete on an international and national level and are older than 12 years of age.
The investigators will measure the athletes' biochemistry in overnight fasted state (micronutrients, including vitamin D (25(OH)D), B12, Ca, Fe, Mg, K and P, lipids, liver enzymes, glucose, creatinine, etc.), their seated blood pressure status, bone mineral density (also segmental) and body composition, using Dual-energy X-ray absorptiometry (DXA), their dietary choice and nutrition intake status, using standardized Food frequency questionnaire (FFQ), their training characteristics, injury status and menstrual status. Athletes who are using vitamin D supplements or who have attended a one-month training camp in the southern geographical zone (Africa) will serve us as control group.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ljubljana, Slovenia, 1000
- Faculty of Sport
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- international and national level
- Signed informed consent for participation in the study
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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gymnasts
Female gymnasts, older than 13 years, with status of ineternational or national level,
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swimmers
Female swimmers, older than 12 years, with status of ineternational or national level,
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences between female gymnasts and swimmers of vitamin D status
Time Frame: April 2018
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Serum 25(OH)D (ng/ml) status after winter time
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April 2018
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences between female gymnasts and swimmers of bone mineral density status
Time Frame: April 2018
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Bone mineral density status (g/cm3) using DEXA
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April 2018
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences between female gymnasts and swimmers of body composition status
Time Frame: April 2018
|
Lean and fat tissue mass (%) assessed dy DEXA
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April 2018
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ivan Čuk, University of Ljubljana, Faculty of Sport, Slovenia
Publications and helpful links
General Publications
- Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Bjelakovic G, Gluud LL, Nikolova D, Whitfield K, Wetterslev J, Simonetti RG, Bjelakovic M, Gluud C. Vitamin D supplementation for prevention of mortality in adults. Cochrane Database Syst Rev. 2014 Jan 10;(1):CD007470. doi: 10.1002/14651858.CD007470.pub3.
- Fuleihan Gel-H, Bouillon R, Clarke B, Chakhtoura M, Cooper C, McClung M, Singh RJ. Serum 25-Hydroxyvitamin D Levels: Variability, Knowledge Gaps, and the Concept of a Desirable Range. J Bone Miner Res. 2015 Jul;30(7):1119-33. doi: 10.1002/jbmr.2536. Epub 2015 May 7.
- Bannert N, Starke I, Mohnike K, Frohner G. [Parameters of mineral metabolism in children and adolescents in athletic training]. Kinderarztl Prax. 1991 May;59(5):153-6. German.
- Lovell G. Vitamin D status of females in an elite gymnastics program. Clin J Sport Med. 2008 Mar;18(2):159-61. doi: 10.1097/JSM.0b013e3181650eee.
- De Keyzer W, Dekkers A, Van Vlaslaer V, Ottevaere C, Van Oyen H, De Henauw S, Huybrechts I. Relative validity of a short qualitative food frequency questionnaire for use in food consumption surveys. Eur J Public Health. 2013 Oct;23(5):737-42. doi: 10.1093/eurpub/cks096. Epub 2012 Jul 26.
- Geiker NRW, Hansen M, Jakobsen J, Kristensen M, Larsen R, Jorgensen NR, Hansen BS, Bugel S. Vitamin D Status and Muscle Function Among Adolescent and Young Swimmers. Int J Sport Nutr Exerc Metab. 2017 Oct;27(5):399-407. doi: 10.1123/ijsnem.2016-0248. Epub 2017 May 30.
- Jakse B, Jakse B, Cuk I, Sajber D. Body Composition, Training Volume/Pattern and Injury Status of Slovenian Adolescent Female High-Performance Gymnasts. Int J Environ Res Public Health. 2021 Feb 19;18(4):2019. doi: 10.3390/ijerph18042019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0120-177/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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