Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT01059968
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2009-12-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low Energy Availability, Menstrual Irregularity, and Low Bone Mass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2009-12-28', 'studyFirstSubmitQcDate': '2010-01-28', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone density', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Energy availability', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bone density', 'energy availability', 'menstrual status', 'female', 'adolescent'], 'conditions': ['Bone Density', 'Energy Availability']}, 'referencesModule': {'references': [{'pmid': '33307469', 'type': 'DERIVED', 'citation': 'Wood KL, Barrack MT, Gray VB, Cotter JA, Van Loan MD, Rauh MJ, McGowan R, Nichols JF. Cognitive dietary restraint score is associated with lower energy, carbohydrate, fat, and grain intake among female adolescent endurance runners. Eat Behav. 2021 Jan;40:101460. doi: 10.1016/j.eatbeh.2020.101460. Epub 2020 Nov 25.'}, {'pmid': '20610635', 'type': 'DERIVED', 'citation': 'Barrack MT, Van Loan MD, Rauh MJ, Nichols JF. Physiologic and behavioral indicators of energy deficiency in female adolescent runners with elevated bone turnover. Am J Clin Nutr. 2010 Sep;92(3):652-9. doi: 10.3945/ajcn.2009.28926. Epub 2010 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the role of energy availability on menstrual function and bone mass in female adolescent endurance athletes. Specific evaluations include dietary intake, exercise energy expenditure, training schedules, menstrual function and bone density.', 'detailedDescription': 'The purpose of this project is to examine the relationships among low energy availability, H-P-A axis, menstrual function and bone density and bone turnover in high school female cross country runners. Our objectives are to: 1)determine energy intake, exercise energy expenditure, and fat-free mass to examine energy availability; 2)in a subset of runners, using double labelled water, estimate total energy expenditure and indirect calorimetry to estimate resting metabolic rate; 3)assess the relationship between energy availability, hormones that regulate bone turnover, markers of bone formation and resorption and bone mineral content and density; 4)identify the relationship between energy availability, hormones that regulate menstrual function and current menstrual status; and 5)determine the energy intake and energy expenditure variables exhibiting the strongest associations with energy availability.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adolescent female cross country runners', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high school female cross country runners\n* ages 15-17 years\n* 1-5 years experience as cross country runner\n* 25 miles or more/week training\n\nExclusion Criteria:\n\n* medications known to affect bone metabolism\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01059968', 'briefTitle': 'Low Energy Availability, Menstrual Irregularity, and Low Bone Mass', 'organization': {'class': 'FED', 'fullName': 'USDA, Western Human Nutrition Research Center'}, 'officialTitle': 'The Role of Low Energy Availability and the H-P-A Axis, Menstrual Irregularity, and Low Bone Mass', 'orgStudyIdInfo': {'id': '200816305-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adolescent female endurance athletes', 'description': 'High school female cross country runners in San Diego.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Marta Van Loan', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Marta D Van Loan, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'USDA, ARS, Western Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA, Western Human Nutrition Research Center', 'class': 'FED'}, 'collaborators': [{'name': 'San Diego State University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Marta Van Loan', 'oldOrganization': 'USDA, ARS, Western Human Nutrition Research Center'}}}}