Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 3:21 PM
Study NCT ID:
NCT04818957
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D Level', 'timeFrame': '12 weeks from starting vitamin D supplementation', 'description': 'Number of participants who achieve 25OH vitamin D level \\>35ng/mL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency', 'Hematopoietic Stem Cell Transplantation (HSCT)']}, 'referencesModule': {'references': [{'pmid': '37285801', 'type': 'DERIVED', 'citation': 'Bartlett AL, Zhang G, Wallace G, McLean S, Myers KC, Teusink-Cross A, Taggart C, Patel B, Davidson R, Davies SM, Jodele S. Optimized vitamin D repletion with oral thin film cholecalciferol in patients undergoing stem cell transplant. Blood Adv. 2023 Aug 22;7(16):4555-4562. doi: 10.1182/bloodadvances.2023009855.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that vitamin D levels can be improved in hematopoietic stem cell transplantation (HSCT) recipients not responding or tolerating standard enteral supplementation options by using vitamin D oral thin film (OTF) administration.', 'detailedDescription': 'The purpose of this study is to investigate efficacy of oral thin film (OTF) cholecalciferol (vitamin D3) replacement in hematopoietic stem cell transplantation (HSCT) recipients who failed to achieve or sustain adequate vitamin D levels after vitamin D supplementation using current standard of care, or those unable to take/tolerate currently available enteral vitamin D formulations. With oral thin film (OTF) cholecalciferol, investigators hope to significantly improve the ease of administration, restoring compliance and facilitating therapeutic vitamin D levels without relying on the gut for absorption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HSCT recipients of any age with vitamin D levels ≤35 ng/mL, or unable to tolerate, or refractory to enteral supplementation formulations of Vitamin D will be offered Vitamin D OTF.\n\nExclusion Criteria:\n\n* Subjects with 25OHD level \\>60ng/mL. Subjects can be re-screened multiple times and enrolled later if they meet study criteria.\n* Subjects with clinically significant and uncontrolled hypercalcemia as deemed by treating physician.'}, 'identificationModule': {'nctId': 'NCT04818957', 'briefTitle': 'Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': '2021-0151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D Oral Thin Film (OTF)', 'description': 'Study subjects will receive vitamin D OTF for a maximum of 12 weeks.', 'interventionNames': ['Dietary Supplement: Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)']}], 'interventions': [{'name': 'Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Study participants will receive vitamin D OTF weekly for a maximum of 12 weeks. The dose may be increased or decreased based on the dosing schema.', 'armGroupLabels': ['Vitamin D Oral Thin Film (OTF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Allison Bartlett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Gregory Wallace, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}