Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-05 @ 3:42 AM
Study NCT ID:
NCT00591604
Status:
WITHDRAWN
Last Update Posted:
2012-11-15
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Vitamin D Deficiency in Burn Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'hurricane caused closure of hospital with PI not associated with Shriners Hospital for children', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-13', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2008-01-10', 'lastUpdatePostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in overall bone health', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['burn', 'vitamin D', 'nutrition', 'burn recovery'], 'conditions': ['Burn']}, 'descriptionModule': {'briefSummary': 'High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content after large burns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5+ yrs\n* Burn size 40% or greater\n* Patient can remain around Shriner Hospital for Children area for 16 weeks\n* Agree to take Vitamin D\n\nExclusion Criteria:\n\n* Age less than 5yrs\n* Burn size less than 40%\n* Pre-existing bone disease or healing fractures\n* Underlying chronic disease-endocrine or cancer\n* Kidney failure'}, 'identificationModule': {'nctId': 'NCT00591604', 'acronym': 'VitaminD', 'briefTitle': 'High-Dose Vitamin D Deficiency in Burn Injury', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Use of High-Dose Vitamin D to Treat Vitamin D Deficiency Following Severe Burn Injury in Children I: A Pilot Study', 'orgStudyIdInfo': {'id': '06-250'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Vitamin D administration', 'interventionNames': ['Drug: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': 'Vitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David N Herndon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}