Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-01-04 @ 12:36 PM
Study NCT ID:
NCT03233295
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2017-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum 25(OH)D concentration', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'serum 1,25(OH)2D concentration', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with vitamin D deficiency\n\nExclusion Criteria:\n\n* Subjects who experienced a hypersensitivity to the cholecalciferol\n* Subjects with Hypercalcemia\n* Subjects with Hypercalciuria\n* Subjects with renal impairment\n* Subjects with calcium stone\n* Subjects diagnosed with sarcoidosis or pseudo-hypoparathyroidism\n* Subjects who are to take vitamin D supplements during the study period'}, 'identificationModule': {'nctId': 'NCT03233295', 'briefTitle': 'A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kwang Dong Pharmaceutical co., ltd.'}, 'officialTitle': 'A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency', 'orgStudyIdInfo': {'id': 'KDBON-CPI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D deficiency', 'interventionNames': ['Drug: Vitamin D3 B.O.N. Injection']}], 'interventions': [{'name': 'Vitamin D3 B.O.N. Injection', 'type': 'DRUG', 'description': 'cholecalciferol 200,000IU', 'armGroupLabels': ['Vitamin D deficiency']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kwang Dong Pharmaceutical co., ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}