Vitamin D DeficiencyNCT03584256
Vitamin D Status Among Competitive Female Gymnast and Swimmers After Winter Time
An observational study of Vitamin D Deficiency and Injuries, run by University of Ljubljana at 1 site in Slovenia.
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… Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Vitamin D Deficiency, Injuries, Cardiovascular Risk Factor
- How many people
- 31 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Apr 2018to 6 Apr 2018
- 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 12 years and older
- Women only
- Child, Adult, Older adult
Study population: Sport
Who may be able to join
- international and national level
- Signed informed consent for participation in the study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Status Relate to Bone Mineral Density, Body Composition and Variey Cardiovascular Risk Factors Among Competitive Female Gymnasts and Swimmers After Winter Time
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.
Read the 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.
- Medical subject headings
- Vitamin D Deficiency, Wounds and Injuries, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gymnasts | Female gymnasts, older than 13 years, with status of ineternational or national level, | |
| swimmers | Female swimmers, older than 12 years, with status of ineternational or national level, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between female gymnasts and swimmers of vitamin D status
Serum 25(OH)D (ng/ml) status after winter time
Measured: April 2018
Secondary outcomes (1)
Differences between female gymnasts and swimmers of bone mineral density status
Bone mineral density status (g/cm3) using DEXA
Measured: April 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start5 Apr 2018
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Barbara Jakše s.p.
- Responsible party
- Sponsor
- Investigators
- Ivan Čuk, Principal investigator, University of Ljubljana, Faculty of Sport, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584256
- Sponsor's protocol ID
- 0120-177/2018
- Status last verified
- Jul 2018
- First submitted
- 23 May 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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;2014(1):CD007470. doi: 10.1002/14651858.CD007470.pub3.
PubMed 24414552Fuleihan 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.
PubMed 25952470Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
PubMed 17634462Bannert 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.
PubMed 1921165Lovell 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.
PubMed 18332692De 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.
PubMed 22843611Geiker 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.
PubMed 28556690Jakse 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.
PubMed 33669675
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status Relate to Bone Mineral Density, Body Composition and Variey Cardiovascular Risk Factors Among Competitive Female Gymnasts and Swimmers After Winter Time
- ClinicalTrials.gov ID
- NCT03584256
- Acronym / sponsor ID
- 0120-177/2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Collaborators
- Barbara Jakše s.p.
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 12 Jul 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gymnasts | – | –Female gymnasts, older than 13 years, with status of ineternational or national level, |
| swimmers | – | –Female swimmers, older than 12 years, with status of ineternational or national level, |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Sport
Key inclusion criteria (2 listed)
- international and national level
- Signed informed consent for participation in the study
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences between female gymnasts and swimmers of vitamin D status
Time frame: April 2018
Serum 25(OH)D (ng/ml) status after winter time
1 secondary outcome
Differences between female gymnasts and swimmers of bone mineral density status
Time frame: April 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Background: PubMed 24414552Bjelakovic 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;2014(1):CD007470. doi: 10.1002/14651858.CD007470.pub3.
- Background: PubMed 25952470Fuleihan 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.
- Background: PubMed 17634462Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Background: PubMed 1921165Bannert 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.
- Background: PubMed 18332692Lovell 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.
- Background: PubMed 22843611De 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.
- Background: PubMed 28556690Geiker 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.
- Derived from this study: PubMed 33669675Jakse 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.
- 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.
Ivan Čuk principal investigator
University of Ljubljana, Faculty of Sport, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Injuries, run by University of Ljubljana at 1 site in Slovenia.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences between female gymnasts and swimmers of vitamin D status (time frame: April 2018). 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 NCT03584256, which also lists 8 linked publications.
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 12 Jul 2018.