Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-25 @ 1:16 PM
Study NCT ID:
NCT01518959
Status:
TERMINATED
Last Update Posted:
2020-07-16
First Post:
2012-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'Insufficient recruitment rate; technical issues with sample storage', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2012-01-06', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Time to treatment needed', 'timeFrame': 'up to 5 years'}, {'measure': 'Blood lymphocyte count', 'timeFrame': 'monthly, up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Lymphoid Leukemia']}, 'descriptionModule': {'briefSummary': 'Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. But data have not proved a causal relationship between the inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown, whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to improve the prognosis and survival.\n\nIn this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years old male or female\n* chronic lymphoid leukaemia, any Rai stage\n* 25-OH-Vitamin-D3 level between 10 and 30 ng/mL\n\nExclusion Criteria:\n\n* serum calcium \\> 2,60 mmol/l\n* 24 hour calcium urine excretion \\> 0,1 mmol/kg/day\n* serum phosphate \\> 1,45 mmol/l\n* eGFR \\< 30 ml/min/1,73m2\n* nephrolithiasis\n* receiving parenteral vitamin-D3 in past 6 months\n* activated vitamin-D3 treatment'}, 'identificationModule': {'nctId': 'NCT01518959', 'acronym': 'D-HEM', 'briefTitle': 'The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases', 'orgStudyIdInfo': {'id': 'D-HEM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'no treatment', 'interventionNames': ['Drug: oleum neutralicum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cholecalcipherol', 'description': 'Treatment with 180 000 IU cholecalcipherol monthly', 'interventionNames': ['Drug: Cholecalciferol']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG', 'description': '180.000 IU monthly', 'armGroupLabels': ['Cholecalcipherol']}, {'name': 'oleum neutralicum', 'type': 'DRUG', 'description': 'Placebo comparator, 9 ml monthly', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University - 1st Departement of Internal Medicine', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Istvan Takacs, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Istvan Takacs', 'investigatorAffiliation': 'Semmelweis University'}}}}