Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-29 @ 10:50 AM
Study NCT ID:
NCT01328704
Status:
COMPLETED
Last Update Posted:
2014-08-25
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Change in Iron, Vitamin D, and C-Reactive Protein Level (CRP) in a 12 to 24 Week Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Blood samples will be obtained three times throughout the course of the subject's involvement in the study: baseline, 3 months, and 6 months."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-22', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-04-04', 'lastUpdatePostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Iron level', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Serum iron levels'}, {'measure': 'Vitamin D level', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Serum Vitamin D 25(OH)D levels'}, {'measure': 'C-Reactive Protein level', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Serum C-reactive protein level'}], 'secondaryOutcomes': [{'measure': 'Ferritin level', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Serum ferritin level'}, {'measure': 'Hemoglobin level', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Serum hemoglobin level'}, {'measure': 'Hematocrit', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Serum hematocrit level'}, {'measure': 'Total Iron Binding Capacity level', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Serum TBC level'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Iron deficiency', 'Vitamin D deficiency', 'Anemia', 'Athletes', 'Triathletes', 'Triathlon'], 'conditions': ['Anemia', 'Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '12480800', 'type': 'BACKGROUND', 'citation': 'Gropper SS, Bader-Crowe DM, McAnulty LS, White BD, Keith RE. Non-anemic iron depletion, oral iron supplementation and indices of copper status in college-aged females. J Am Coll Nutr. 2002 Dec;21(6):545-52. doi: 10.1080/07315724.2002.10719253.'}, {'pmid': '17046553', 'type': 'BACKGROUND', 'citation': 'Kelley GA, Kelley KS. Effects of aerobic exercise on C-reactive protein, body composition, and maximum oxygen consumption in adults: a meta-analysis of randomized controlled trials. Metabolism. 2006 Nov;55(11):1500-7. doi: 10.1016/j.metabol.2006.06.021.'}, {'pmid': '11183845', 'type': 'BACKGROUND', 'citation': 'Malczewska J, Raczynski G, Stupnicki R. Iron status in female endurance athletes and in non-athletes. Int J Sport Nutr Exerc Metab. 2000 Sep;10(3):260-276. doi: 10.1123/ijsnem.10.3.260.'}, {'pmid': '3041528', 'type': 'BACKGROUND', 'citation': 'Newhouse IJ, Clement DB. Iron status in athletes. An update. Sports Med. 1988 Jun;5(6):337-52. doi: 10.2165/00007256-198805060-00001.'}, {'pmid': '15284086', 'type': 'BACKGROUND', 'citation': 'Okita K, Nishijima H, Murakami T, Nagai T, Morita N, Yonezawa K, Iizuka K, Kawaguchi H, Kitabatake A. Can exercise training with weight loss lower serum C-reactive protein levels? Arterioscler Thromb Vasc Biol. 2004 Oct;24(10):1868-73. doi: 10.1161/01.ATV.0000140199.14930.32. Epub 2004 Jul 29.'}, {'pmid': '17909397', 'type': 'BACKGROUND', 'citation': 'Stewart LK, Flynn MG, Campbell WW, Craig BA, Robinson JP, Timmerman KL, McFarlin BK, Coen PM, Talbert E. The influence of exercise training on inflammatory cytokines and C-reactive protein. Med Sci Sports Exerc. 2007 Oct;39(10):1714-9. doi: 10.1249/mss.0b013e31811ece1c.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe changes in iron status and vitamin D status during a 12-24 week supervised training program, specifically males and females between the ages of 30 and 50 years old.', 'detailedDescription': 'Study subjects will be participants in a triathlon training program through the Avera Sports Institute in Sioux Falls, SD. This clinical study will examine changes in iron and vitamin D levels. Blood specimens will be collected at baseline and again after 3 and 6 months of participating in the training program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and pre-menopausal women between the ages of 30 and 50 who are participating in the Triathlon Training Program through the Avera Sports Institute', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and premenopausal females between the ages of 30 and 50 years old\n* Training through the Avera Sports Institute Triathlon Training Program\n* Agree to keep diet, exercise and all current health habits stable during participation in the study\n\nExclusion Criteria:\n\n* Women who are pregnant, breastfeeding or planning to become pregnant\n* Has a chronic disease that affects calcium or bone metabolism\n* Has a chronic disease that affects iron metabolism or iron storage\n* Has kidney disease\n* Has any laboratory or biometric value that would indicate an issue for the safety of the study subject\n* Is currently participating in another clinical research study'}, 'identificationModule': {'nctId': 'NCT01328704', 'briefTitle': 'Evaluate the Change in Iron, Vitamin D, and C-Reactive Protein Level (CRP) in a 12 to 24 Week Period', 'organization': {'class': 'OTHER', 'fullName': 'Avera McKennan Hospital & University Health Center'}, 'officialTitle': 'Observational Study to Evaluate Changes in Iron, Vit-D, and CRP During a Twelve to Twenty-Four Week Supervised Triathlon Training Program', 'orgStudyIdInfo': {'id': 'ARI-1390-Triathletes'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Triathletes', 'description': 'Group of individuals who are participating in a triathlon training program at the Avera Sports Institute'}]}, 'contactsLocationsModule': {'locations': [{'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Sports Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'Matthew Vukovich, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Dakota State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avera McKennan Hospital & University Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}