Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 3:44 PM
Study NCT ID:
NCT01100905
Status:
COMPLETED
Last Update Posted:
2010-04-26
First Post:
2010-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Iron-containing Food Product for the Prevention of Diminished Iron Status in Soldiers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'lastUpdateSubmitDate': '2010-04-23', 'studyFirstSubmitDate': '2010-04-07', 'studyFirstSubmitQcDate': '2010-04-08', 'lastUpdatePostDateStruct': {'date': '2010-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iron', 'Iron status', 'Iron deficiency', 'Iron deficiency anemia'], 'conditions': ['Iron Deficiency', 'Iron Deficiency Anemia']}, 'referencesModule': {'references': [{'pmid': '20444958', 'type': 'DERIVED', 'citation': 'Karl JP, Lieberman HR, Cable SJ, Williams KW, Young AJ, McClung JP. Randomized, double-blind, placebo-controlled trial of an iron-fortified food product in female soldiers during military training: relations between iron status, serum hepcidin, and inflammation. Am J Clin Nutr. 2010 Jul;92(1):93-100. doi: 10.3945/ajcn.2010.29185. Epub 2010 May 5.'}]}, 'descriptionModule': {'briefSummary': 'Military personnel face intense physical and cognitive demands. Diminished iron status affects physiologic responses to these challenges. Both cross-sectional and longitudinal studies indicate a significant decrement in iron status in enlisted female military personnel immediately following basic combat training (BCT). Decrements in iron status are associated with diminished cognitive and physical performance, and may affect body composition. The primary objective of this randomized, placebo controlled study is to assess the utility of an iron-containing food product for maintaining iron status during BCT. This study will provide insight into the utility and efficacy of an iron-containing food product for the maintenance of iron status during military training. Furthermore, it will provide novel scientific data regarding the relationship between iron status and physical and cognitive performance in female Soldiers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female US Army Recruit\n* Participating in Basic Combat Training\n\nExclusion Criteria:\n\n* Male\n* Pregnancy\n* Diagnosed hemochromatosis\n* Diagnosed thalassemia\n* History of ulcerative colitis\n* Allergy to chocolate'}, 'identificationModule': {'nctId': 'NCT01100905', 'briefTitle': 'An Iron-containing Food Product for the Prevention of Diminished Iron Status in Soldiers', 'organization': {'class': 'FED', 'fullName': 'United States Army Research Institute of Environmental Medicine'}, 'officialTitle': 'Utility of an Iron-containing Food Product for the Prevention of Diminished Iron Status During Basic Combat Training', 'orgStudyIdInfo': {'id': 'H08-11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Iron-containing food product', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29207', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Fort Jackson', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Army Research Institute of Environmental Medicine', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'James P. McClung, Ph.D.', 'oldOrganization': 'USARIEM'}}}}