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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03584256
Other study ID # 0120-177/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 5, 2018
Est. completion date April 6, 2018

Study information

Verified date July 2018
Source University of Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

As indoor athletes, competitive gymnasts and swimmers can face the problem of a potential vitamin D deficiency. In the last decades, indoor sports participants have been faced with the problem of an institutionalized lifestyle and, in some places, a lower exposure to sun, which is also associated with the geographical area with a lower or higher UV index, especially in autumn, winter, and early spring (from October to April), when the day is shorter and the clock shifts to winter time. The problem with gymnasts and swimmers lies in daily trainings in the gym and pool and in the daily rest between two trainings, which can be spend more or less institutionally. The investigators wanted to examine the vitamin D status related to bone mineral density, body composition and various cardiovascular markers among young competitive gymnasts and swimmers after winter time. The investigators want to potentially give more solid but sensible recommendations for trainers, athletes, parents and sports doctors when it comes to vitamin D supplementations for indoor female athletes.


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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date April 6, 2018
Est. primary completion date April 6, 2018
Accepts healthy volunteers
Gender Female
Age group 12 Years and older
Eligibility Inclusion Criteria:

- international and national level

- Signed informed consent for participation in the study

Exclusion Criteria:

Study Design


Locations

Country Name City State
Slovenia Faculty of Sport Ljubljana

Sponsors (2)

Lead Sponsor Collaborator
University of Ljubljana Barbara Jakše s.p.

Country where clinical trial is conducted

Slovenia, 

References & Publications (7)

Bannert N, Starke I, Mohnike K, Fröhner G. [Parameters of mineral metabolism in children and adolescents in athletic training]. Kinderarztl Prax. 1991 May;59(5):153-6. German. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Geiker NRW, Hansen M, Jakobsen J, Kristensen M, Larsen R, Jørgensen NR, Hansen BS, Bügel 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. — View Citation

Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Differences between female gymnasts and swimmers of body composition status Lean and fat tissue mass (%) assessed dy DEXA April 2018
Primary Differences between female gymnasts and swimmers of vitamin D status Serum 25(OH)D (ng/ml) status after winter time April 2018
Secondary Differences between female gymnasts and swimmers of bone mineral density status Bone mineral density status (g/cm3) using DEXA April 2018
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