Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00285467
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2006-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}], 'ancestors': [{'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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': 'C042533', 'term': '1 alpha-hydroxyergocalciferol'}, {'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': 'smoe@iupui.edu', 'phone': '317-278-2868', 'title': 'Sharon Moe, MD', 'organization': 'Indiana University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Larger, long term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related endpoints and safety.'}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Doxercalciferol, Active Vitamin D', 'description': 'Doxercalciferol is an active Vitamin D readily usable by human body.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cholecalciferol, Inactive Vitamin D', 'description': 'Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Reduction in PTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxercalciferol, Active Vitamin D', 'description': 'Doxercalciferol is an active Vitamin D readily usable by human body.'}, {'id': 'OG001', 'title': 'Cholecalciferol, Inactive Vitamin D', 'description': 'Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '34', 'groupId': 'OG000'}, {'value': '10', 'spread': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 month', 'description': 'Percent reduction in PTH from baseline to 3 months', 'unitOfMeasure': '% change in PTH baseline to 3 months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The initial sample size was based on the published response to doxercalciferol versus placebo where a 46% reduction in PTH was observed over 6 months, with a 51% SD. The expected reduction in PTH with cholecalciferol was based on the best-case scenario decrease of 17.8% in PTH with ergocalciferol from our own clinic setting.'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxercalciferol, Active Vitamin D', 'description': 'Doxercalciferol is an active Vitamin D readily usable by human body.'}, {'id': 'OG001', 'title': 'Cholecalciferol, Inactive Vitamin D', 'description': 'Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'spread': '47', 'groupId': 'OG000'}, {'value': '128', 'spread': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 month', 'description': 'systolic blood pressure at 3 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Doxercalciferol, Active Vitamin D', 'description': 'Doxercalciferol is an active Vitamin D readily usable by human body.'}, {'id': 'FG001', 'title': 'Cholecalciferol, Inactive Vitamin D', 'description': 'Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Doxercalciferol, Active Vitamin D', 'description': 'Doxercalciferol is an active Vitamin D readily usable by human body.'}, {'id': 'BG001', 'title': 'Cholecalciferol, Inactive Vitamin D', 'description': 'Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '10', 'groupId': 'BG000'}, {'value': '62', 'spread': '10', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '55 subjects were consents and underwent qualifying blood tests. 47 subjects were randomized to treatment: 25 to doxercalciferol and 22 to cholecalciferol.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '47 subjects had at least one follow up visit after taking medications and were included in results.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2006-01-31', 'resultsFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2006-01-31', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-18', 'studyFirstPostDateStruct': {'date': '2006-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Reduction in PTH', 'timeFrame': '3 month', 'description': 'Percent reduction in PTH from baseline to 3 months'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure at 3 Months', 'timeFrame': '3 month', 'description': 'systolic blood pressure at 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['kidney, parathyroid hormone, vitamin d'], 'conditions': ['Renal Osteodystrophy']}, 'referencesModule': {'references': [{'pmid': '20056760', 'type': 'RESULT', 'citation': 'Moe SM, Saifullah A, LaClair RE, Usman SA, Yu Z. A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney disease. Clin J Am Soc Nephrol. 2010 Feb;5(2):299-306. doi: 10.2215/CJN.07131009. Epub 2010 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in blood pressure.', 'detailedDescription': 'Patients with CKD stage 3 were randomly allocated (by blinded group allocation) to either cholecalciferol (4000 U per day for one month then 2000 IU daily thereafter) or doxercalciferol (2.5 mcg po daily. Assessments for blood endpoints (primary end point PTH; secondary calcium, phosphorus) were done monthly. Other assessments (blood pressure) were done at baseline and at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years old or older, male or female\n* able to sign informed consent\n* CKD stage 3 (GFR 30-59 ml/min) or stage 4 (15-29 ml/min)\n* intact Parathyroid hormone level (iPTH) \\> 100 pg/ml for stage 3 or iPTH \\> 150 pg/ml for stage 4\n* calcidiol levels ≤ 20 ng/ml\n* ability to ambulate without assistance\n\nExclusion Criteria:\n\n* intact PTH \\> 400 pg/ml\n* initial corrected Calcium \\> 9.7 mg/dl\n* initial serum Phosphorous \\> 5.0 mg/dl\n* initial standardized blood pressure of \\> 160/100\n* history of significant liver disease or cirrhosis\n* anticipated requirement for dialysis in 6 months\n* malabsorption, severe chronic diarrhea, or ileostomy\n* no calcimimetic or active vitamin D therapy 30 days prior to enrollment\n* use of digoxin, magnesium containing products, mineral oil, or cholestyramine'}, 'identificationModule': {'nctId': 'NCT00285467', 'briefTitle': 'Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in CKD', 'orgStudyIdInfo': {'id': '0508-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Doxercalciferol', 'description': 'doxercalciferol 1 mcg capsule orally daily for 3 months. This is a form of vitamin D that does not require activation by enzymes in the liver and kidney.', 'interventionNames': ['Drug: doxercalciferol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cholecalciferol', 'description': 'cholecalciferol 4000 IU capsule orally daily for one month, then 2000 IU capsule daily orally for 2 months. this form of vitamin D requires activation by cells of the body.', 'interventionNames': ['Drug: Cholecalciferol']}], 'interventions': [{'name': 'doxercalciferol', 'type': 'DRUG', 'otherNames': ['Hectoral'], 'description': 'form of vitamin D that is already in active form.', 'armGroupLabels': ['Doxercalciferol']}, {'name': 'Cholecalciferol', 'type': 'DRUG', 'otherNames': ['vitamin D3'], 'description': 'from of vitamin D that requires cells in the body to make active', 'armGroupLabels': ['Cholecalciferol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Sharon Moe, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}