Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-04-04 @ 1:31 AM
Study NCT ID:
NCT01897168
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-30
First Post:
2013-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Mineral Content in Healthy Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and urine may be collected from study participants.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone health assessed by pQCT and DXA', 'timeFrame': '5-7 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the effects of early diet on bone health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current or past participation in the Beginnings study (IRB#07180)\n* Age 5-7 years\n\nExclusion Criteria:\n\n* Growth or bone disorders\n* Non-removal metal on participant\n* Any other conditions that may affect the outcome of interest as determined by the PI.'}, 'identificationModule': {'nctId': 'NCT01897168', 'briefTitle': 'Bone Mineral Content in Healthy Children', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Bone Mineral Content in Healthy Children', 'orgStudyIdInfo': {'id': '135180'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No grouping', 'interventionNames': ['Device: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'DEVICE', 'armGroupLabels': ['No grouping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Nutrition Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Jin-Ran Chen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Arkansas Children's Nutrition Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}