Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT01633658
Status:
WITHDRAWN
Last Update Posted:
2013-05-29
First Post:
2012-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Protocol has changed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-27', 'studyFirstSubmitDate': '2012-07-02', 'studyFirstSubmitQcDate': '2012-07-03', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum 25(OH)D response', 'timeFrame': '28 days', 'description': '25(OH)D will be measured at frequent time intervals over 28 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D'], 'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.', 'detailedDescription': 'Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ten men and women in each group,\n* aged 20-60.\n\nExclusion Criteria:\n\n* History of hypercalcemia,\n* vitamin D supplement use \\> 800 IU daily,\n* BMI \\> 30,\n* gastrointestinal malabsorption (from celiac sprue, colitis, surgery, etc.), kidney disease or liver disease,\n* use of steroids in any form,\n* anticonvulsants,\n* antibiotics,\n* acute illness, or\n* vacation planned to "sunny climate"'}, 'identificationModule': {'nctId': 'NCT01633658', 'briefTitle': 'The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study', 'orgStudyIdInfo': {'id': 'Creighton 13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D Cholecalciferol', 'description': 'A single dose of 2500 micrograms cholecalciferol', 'interventionNames': ['Dietary Supplement: cholecalciferol']}, {'type': 'EXPERIMENTAL', 'label': '25(OH)D', 'description': 'A single dose of 625 micrograms 25(OH)D', 'interventionNames': ['Dietary Supplement: 25(OH)D']}], 'interventions': [{'name': 'cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a single dose of 2500 micrograms of cholecalciferol', 'armGroupLabels': ['Vitamin D Cholecalciferol']}, {'name': '25(OH)D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a single dose of 625 micrograms of 25(OH)D', 'armGroupLabels': ['25(OH)D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Laura Armas, MD,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}