Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-02 @ 7:51 PM
Study NCT ID:
NCT01222234
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2010-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Vitamin D Therapies on Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jstubbs@kumc.edu', 'phone': '913-588-9252', 'title': 'Dr. Jason Stubbs', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Cholecalciferol', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.\n\nCholecalciferol: Cholecalciferol tablet, 50,000 units twice a week', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: Calcitriol', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.\n\ncalcitriol: calcitriol 0.25 mcg every day', 'otherNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3: Cholecalciferol', 'description': 'Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.\n\nCholecalciferol: Cholecalciferol tablet, 50,000 units twice a week', 'otherNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Monocyte Protein Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Cholecalciferol - CKD', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.\n\nCholecalciferol 50,000 IU twice weekly for 8 weeks'}, {'id': 'OG001', 'title': 'Group 2: Calcitriol - CKD', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.\n\nCalcitriol 0.25 mcg every day'}], 'classes': [{'title': 'CD14', 'categories': [{'measurements': [{'value': '34110', 'spread': '9372', 'groupId': 'OG000'}, {'value': '38540', 'spread': '16880', 'groupId': 'OG001'}]}]}, {'title': 'ACE', 'categories': [{'measurements': [{'value': '1359', 'spread': '347.2', 'groupId': 'OG000'}, {'value': '1360', 'spread': '290.8', 'groupId': 'OG001'}]}]}, {'title': 'VDR', 'categories': [{'measurements': [{'value': '2799', 'spread': '1210', 'groupId': 'OG000'}, {'value': '3468', 'spread': '3123', 'groupId': 'OG001'}]}]}, {'title': 'Mac-1', 'categories': [{'measurements': [{'value': '14318', 'spread': '4196.4', 'groupId': 'OG000'}, {'value': '14278.5', 'spread': '4891.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks of therapy', 'description': 'Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression', 'unitOfMeasure': 'relative fluorescence units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary comparison for this outcome was between only CKD groups (groups 1 and 2); therefore data from the non-CKD group (group 3) was not analyzed for this outcome. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.'}, {'type': 'PRIMARY', 'title': 'Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: CKD Cholecalciferol', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.\n\nCholecalciferol: Cholecalciferol tablet, 50,000 units twice a week'}, {'id': 'OG001', 'title': 'Group 3: Non-CKD Cholecalciferol', 'description': 'Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.\n\nCholecalciferol: Cholecalciferol tablet, 50,000 units twice a week'}], 'classes': [{'categories': [{'measurements': [{'value': '1.59', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '3.59', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks of therapy', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary comparison for this outcome of interest was between subjects taking cholecalciferol, so the calcitriol group (group 2) was excluded from the analysis. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Cholecalciferol', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.\n\nCholecalciferol: Cholecalciferol tablet, 50,000 units twice a week'}, {'id': 'FG001', 'title': 'Group 2: Calcitriol', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.\n\ncalcitriol: calcitriol 0.25 mcg every day'}, {'id': 'FG002', 'title': 'Group 3: Cholecalciferol', 'description': 'Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.\n\nCholecalciferol: Cholecalciferol tablet, 50,000 units twice a week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Cholecalciferol', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.\n\nCholecalciferol: Cholecalciferol tablet, 50,000 units twice a week'}, {'id': 'BG001', 'title': 'Group 2: Calcitriol', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.\n\ncalcitriol: calcitriol 0.25 mcg every day'}, {'id': 'BG002', 'title': 'Group 3: Cholecalciferol', 'description': 'Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.\n\nCholecalciferol: Cholecalciferol tablet, 50,000 units twice a week'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '48.5', 'spread': '14.2', 'groupId': 'BG002'}, {'value': '56.1', 'spread': '13.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2010-10-13', 'resultsFirstSubmitDate': '2015-11-24', 'studyFirstSubmitQcDate': '2010-10-15', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-11', 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monocyte Protein Expression', 'timeFrame': '8 weeks of therapy', 'description': 'Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression'}, {'measure': 'Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol', 'timeFrame': '8 weeks of therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease (CKD)', 'End-stage Renal Disease (ESRD)']}, 'descriptionModule': {'briefSummary': 'This investigation will consist of a prospective study utilizing two separate populations of patients with 25(OH)D deficiency, one population with chronic kidney disease (CKD) and one with normal renal function.', 'detailedDescription': 'Vitamin D helps form and strengthens bones by allowing the body to absorb calcium. Vitamin D helps the immune system fight infection as well as helps keep muscles strong. Without enough vitamin D, bones can become weak, thin and brittle.\n\nVitamin D is useful in people with all different types of health issues. CKD is the slow loss of kidney function over time. The main function of the kidneys is to remove wastes and excess water from the body. This loss of function usually takes months or years to occur Patients with CKD often have low levels of vitamin D in their blood.\n\nThis study will have two groups of patients with CKD and one group of patients that have normal kidney function, but all groups will have low levels of vitamin D. The two groups with CKD (group 1 and group 2) will receive either cholecalciferol or calcitriol. The purpose of having a control group (group 3) without CKD will be to evaluate if any changes that are witnessed in response to vitamin D therapy are specific to patients with kidney disease or apply to all patients with vitamin D deficiency who receive vitamin D supplements.\n\nThere are two different drugs in this study. One is called Calcitriol and is approved by the Food and Drug Administration (FDA) as a vitamin D supplement. The other drug is called cholecalciferol and it is approved by the FDA. Unlike calcitriol, cholecalciferol is a nutritional form of vitamin D that can often be found in various types of foods and its chemical structure must be changed by the body to become the active form of vitamin D. It is believed that cholecalciferol may have different effects in the body compared to calcitriol. It is possible that CKD patients would benefit from receiving both of these drugs, but this is currently unclear. While on this study you will receive either one of these study drugs, depending on which group you are assigned to.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic kidney disease w/GFR\\<35ml/min\n* Nutritional vitamin D deficiency, defined as 25(OH)D \\< 25ng/ml\n* Secondary hyperparathyroidism, PTH\\>75pg/mL\n\nExclusion Criteria:\n\n* Active infection\n* Recent hospitalization for acute illness (within last month)\n* Refusal to study participation\n* History of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, SLE, etc.)\n* Allergy to cholecalciferol or calcitriol\n* History of parathyroidectomy\n* Functional renal transplant within 5 years\n* Current treatment with immunosuppressant medications\n* Noncompliance with prescribed medications'}, 'identificationModule': {'nctId': 'NCT01222234', 'briefTitle': 'Impact of Vitamin D Therapies on Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Impact of Vitamin D Therapies on Monocyte Function in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '11936'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Cholecalciferol - CKD', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.', 'interventionNames': ['Drug: Cholecalciferol - CKD']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Calcitriol - CKD', 'description': 'Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). They will be administered calcitriol 0.25mcg daily for 8 weeks.', 'interventionNames': ['Device: Calcitriol - CKD']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Cholecalciferol - non-CKD', 'description': 'Patients in this arm have low vitamin D levels and normal kidney function. They will be administered cholecalciferol 50,000 IU twice weekly for 8 weeks.', 'interventionNames': ['Drug: Cholecalciferol - non-CKD']}], 'interventions': [{'name': 'Cholecalciferol - CKD', 'type': 'DRUG', 'otherNames': ['Vitamin D3'], 'description': 'Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks', 'armGroupLabels': ['Group 1: Cholecalciferol - CKD']}, {'name': 'Calcitriol - CKD', 'type': 'DEVICE', 'otherNames': ['1,25(OH)2D'], 'description': 'Calcitriol 0.25 mcg once daily for 8 weeks', 'armGroupLabels': ['Group 2: Calcitriol - CKD']}, {'name': 'Cholecalciferol - non-CKD', 'type': 'DRUG', 'otherNames': ['Vitamin D3'], 'description': 'Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks', 'armGroupLabels': ['Group 3: Cholecalciferol - non-CKD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University Of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Jason Stubbs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jason Stubbs, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}