Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT03584256
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2018-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D Status Among Competitive Female Gymnast and Swimmers After Winter Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Differences between female gymnasts and swimmers of body composition status', 'timeFrame': 'April 2018', 'description': 'Lean and fat tissue mass (%) assessed dy DEXA'}], 'primaryOutcomes': [{'measure': 'Differences between female gymnasts and swimmers of vitamin D status', 'timeFrame': 'April 2018', 'description': 'Serum 25(OH)D (ng/ml) status after winter time'}], 'secondaryOutcomes': [{'measure': 'Differences between female gymnasts and swimmers of bone mineral density status', 'timeFrame': 'April 2018', 'description': 'Bone mineral density status (g/cm3) using DEXA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency', 'Injuries', 'Cardiovascular Risk Factor', 'Nutritional Deficiency']}, 'referencesModule': {'references': [{'pmid': '24414552', 'type': 'BACKGROUND', '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;2014(1):CD007470. doi: 10.1002/14651858.CD007470.pub3.'}, {'pmid': '25952470', 'type': 'BACKGROUND', '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.'}, {'pmid': '17634462', 'type': 'BACKGROUND', 'citation': 'Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.'}, {'pmid': '1921165', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18332692', 'type': 'BACKGROUND', '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.'}, {'pmid': '22843611', 'type': 'BACKGROUND', '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.'}, {'pmid': '28556690', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33669675', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nInternational 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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sport', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* international and national level\n* Signed informed consent for participation in the study\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03584256', 'briefTitle': 'Vitamin D Status Among Competitive Female Gymnast and Swimmers After Winter Time', 'organization': {'class': 'OTHER', 'fullName': 'University of Ljubljana'}, 'officialTitle': 'Vitamin D Status Relate to Bone Mineral Density, Body Composition and Variey Cardiovascular Risk Factors Among Competitive Female Gymnasts and Swimmers After Winter Time', 'orgStudyIdInfo': {'id': '0120-177/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'gymnasts', 'description': 'Female gymnasts, older than 13 years, with status of ineternational or national level,'}, {'label': 'swimmers', 'description': 'Female swimmers, older than 12 years, with status of ineternational or national level,'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Faculty of Sport', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Ivan Čuk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ljubljana, Faculty of Sport, Slovenia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ljubljana', 'class': 'OTHER'}, 'collaborators': [{'name': 'Barbara Jakše s.p.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}