Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT01306656
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2011-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Vitamin D Repletion in Primary Hyperparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049950', 'term': 'Hyperparathyroidism, Primary'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D014807', 'term': 'Vitamin D'}], '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': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sjs7@cumc.columbia.edu', 'phone': '212-305-6291', 'title': 'Shonni Silverberg, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study enrollment did not reach the required number of subjects; the analysis results would not have been reliable or have enough statistical power. Therefore, samples were not processed and data was not analyzed.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Definitions do not differ from those of the ClinicalTrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': '10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D\n\n10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week\n\nMonths 2-6: 10,000 IU vitamin D3 once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Placebo plus a multivitamin with 400 IU vitamin D\n\nPlacebo: Month 1: Placebo once a week\n\nMonths 2-6: Placebo once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infection', 'notes': 'Urinary infection - E. Coli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'notes': 'Constipation for 5 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Stones', 'notes': 'right nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Parathyroid Hormone (PTH) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10,000 IU Vitamin D3 + Multivitamin', 'description': '10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D\n\n10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week\n\nMonths 2-6: 10,000 IU vitamin D3 once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}, {'id': 'OG001', 'title': 'Placebo + Multivitamin', 'description': 'Placebo plus a multivitamin with 400 IU vitamin D\n\nPlacebo: Month 1: Placebo once a week\n\nMonths 2-6: Placebo once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}], 'timeFrame': '6 months', 'description': 'This is designed to measure how many participants will achieve PTH \\> 65 pg/mL.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study enrollment did not reach the required number of subjects; the analysis results would not have been reliable or have enough statistical power. Therefore, samples were not processed and data was not available for analysis.'}, {'type': 'SECONDARY', 'title': 'Areal Bone Mineral Density of the Lumbar Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10,000 IU Vitamin D3 + Multivitamin', 'description': '10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D\n\n10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week\n\nMonths 2-6: 10,000 IU vitamin D3 once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}, {'id': 'OG001', 'title': 'Placebo + Multivitamin', 'description': 'Placebo plus a multivitamin with 400 IU vitamin D\n\nPlacebo: Month 1: Placebo once a week\n\nMonths 2-6: Placebo once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.98777', 'spread': '1.662643', 'groupId': 'OG000'}, {'value': '1.442861', 'spread': '4.376592', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Measured by dual-energy x-ray absorptiometry (DEXA) scan', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study enrollment did not reach the required number of subjects; the analysis results are not reliable or have enough statistical power.'}, {'type': 'SECONDARY', 'title': 'Trabecular Bone Density at the Forearm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D\n\n10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week\n\nMonths 2-6: 10,000 IU vitamin D3 once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Placebo plus a multivitamin with 400 IU vitamin D\n\nPlacebo: Month 1: Placebo once a week\n\nMonths 2-6: Placebo once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00345', 'spread': '3.912386', 'groupId': 'OG000'}, {'value': '-2.59816', 'spread': '0.583978', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Measured by high resolution peripheral quantitative computed tomography', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study enrollment did not reach the required number of subjects; the analysis results are not reliable nor have enough statistical power.'}, {'type': 'SECONDARY', 'title': 'Change in Urinary Calcium Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10,000 IU Vitamin D3 + Multivitamin', 'description': '10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D\n\n10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week\n\nMonths 2-6: 10,000 IU vitamin D3 once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}, {'id': 'OG001', 'title': 'Placebo + Multivitamin', 'description': 'Placebo plus a multivitamin with 400 IU vitamin D\n\nPlacebo: Month 1: Placebo once a week\n\nMonths 2-6: Placebo once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}], 'classes': [{'title': '1-month', 'categories': [{'measurements': [{'value': '182.67', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '453'}, {'value': '154', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '232'}]}]}, {'title': '3-month', 'categories': [{'measurements': [{'value': '172.67', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '282'}, {'value': '115.5', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '180'}]}]}, {'title': '6-month', 'categories': [{'measurements': [{'value': '195.17', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '387'}, {'value': '50.5', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month, 3 months, 6 months', 'description': 'This is designed to measure how the study treatment will affect urinary calcium level over time.', 'unitOfMeasure': 'mg/day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is provided for 6 out of the 7 participants in Group 1 due to that 1 participant became lost to follow-up and did not complete lab testing at Month 3 and 6.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10,000 IU Vitamin D3 + Multivitamin', 'description': '10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D\n\n10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week\n\nMonths 2-6: 10,000 IU vitamin D3 once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}, {'id': 'FG001', 'title': 'Placebo + Multivitamin', 'description': 'Placebo plus a multivitamin with 400 IU vitamin D\n\nPlacebo: Month 1: Placebo once a week\n\nMonths 2-6: Placebo once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '10,000 IU Vitamin D3 + Multivitamin', 'description': '10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D\n\n10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week\n\nMonths 2-6: 10,000 IU vitamin D3 once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}, {'id': 'BG001', 'title': 'Placebo + Multivitamin', 'description': 'Placebo plus a multivitamin with 400 IU vitamin D\n\nPlacebo: Month 1: Placebo once a week\n\nMonths 2-6: Placebo once a week\n\nVitamin D: Daily multivitamin with 400 IU vitamin D.'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-02', 'size': 267508, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-01T16:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patient, investigator and study team will be blinded to study arm ramdomization.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Active arm:\n\nMonth 1: 20,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D.\n\nMonths 2-6: 10,000 IU vitamin D3 once a week, plus daily multivitamin with 400 IU vitamin D.\n\nPlacebo arm:\n\nMonth 1: Placebo once a week plus daily multivitamin with 400 IU vitamin D.\n\nMonths 2-6: Placebo every week plus daily multivitamin with 400 IU vitamin D.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'dispFirstSubmitDate': '2018-03-05', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2011-02-10', 'dispFirstSubmitQcDate': '2018-03-15', 'resultsFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2011-02-28', 'dispFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-21', 'studyFirstPostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Parathyroid Hormone (PTH) Level', 'timeFrame': '6 months', 'description': 'This is designed to measure how many participants will achieve PTH \\> 65 pg/mL.'}], 'secondaryOutcomes': [{'measure': 'Areal Bone Mineral Density of the Lumbar Spine', 'timeFrame': '6 months', 'description': 'Measured by dual-energy x-ray absorptiometry (DEXA) scan'}, {'measure': 'Trabecular Bone Density at the Forearm', 'timeFrame': '6 months', 'description': 'Measured by high resolution peripheral quantitative computed tomography'}, {'measure': 'Change in Urinary Calcium Level', 'timeFrame': '1 month, 3 months, 6 months', 'description': 'This is designed to measure how the study treatment will affect urinary calcium level over time.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endocrinology', 'Metabolic Bone Disease', 'Primary Hyperparathyroidism', 'PHPT', 'Vitamin D Deficiency', 'Bone Mineral Density', 'Hyper-calcemia'], 'conditions': ['Primary Hyperparathyroidism', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'This study will look at the effect of 2 treatment regimens that contain vitamin D in a six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine and bones. This study should provide important information on the effect of vitamin D therapy in patients with PHPT. In addition, data from this study will guide physicians as to how best to treat their patients who have PHPT and vitamin D deficiency.', 'detailedDescription': 'Primary hyperparathyroidism (PHPT) is a common disease in which the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. In primary hyperparathyroidism, high levels of PTH remove too much calcium from bones and deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by the excess calcium loss which weakens the structure of the bones.\n\nMany patients with primary hyperparathyroidism also have low vitamin D (25OHD) levels which is thought to further impair bone health. Recent medical guidelines recommend treating patients with primary hyperparathyroidism who have low vitamin D levels with oral vitamin D but the optimal vitamin D dose and rate of repletion is unclear. It is, therefore, important to determine if replenishing Vitamin D will improve bone health in primary hyperparathyroidism, and if so, to assess the impact of the rate of vitamin D repletion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed PHPT, defined by an elevated serum calcium level (we will not study normocalcemic PHPT) with elevated or inappropriately normal PTH levels.\n* Vitamin D3 less than 30 ng/ml\n\nExclusion Criteria:\n\n* Patients with familial hyperparathyroid syndromes\n* Current or past use of the following medications: bisphosphonate within past 2 years, use of lithium or thiazide diuretics, current use of cinacalcet, use of aluminum containing medications, cimetidine, colestipol, or orlistat\n* Malignancy, except cured basal or squamous cell skin carcinoma or other cured cancers that are at least five years free from recurrence\n* History or current diagnosis of certain medical diseases (including sarcoidosis, active infectious granulomatous disease, HIV/AIDS, chronic kidney disease (serum creatinine \\> 1.5 mg/dL), liver disease; GI diseases known to affect calcium metabolism; secondary hyperparathyroidism);\n* We will also exclude patients with calcium above 11.5 mg/dL, urine calcium above 350 mg/day, and active nephrolithiasis because vitamin D repletion could potentially exacerbate hypercalcemia or hypercalciuria\n* Other exclusions include protected individuals (institutionalized), prisoners, and any other prospective participant who might not be able to give voluntary informed consent.'}, 'identificationModule': {'nctId': 'NCT01306656', 'briefTitle': 'Vitamin D Repletion in Primary Hyperparathyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism', 'orgStudyIdInfo': {'id': 'AAAF1797'}, 'secondaryIdInfos': [{'id': 'R01DK084986-05', 'link': 'https://reporter.nih.gov/quickSearch/R01DK084986-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D', 'interventionNames': ['Drug: 10,000 IU Vitamin D3', 'Dietary Supplement: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'Placebo plus a multivitamin with 400 IU vitamin D', 'interventionNames': ['Other: Placebo', 'Dietary Supplement: Vitamin D']}], 'interventions': [{'name': '10,000 IU Vitamin D3', 'type': 'DRUG', 'otherNames': ['Cholecalciferol-D3'], 'description': 'Month 1: 20,000 IU vitamin D3 once a week\n\nMonths 2-6: 10,000 IU vitamin D3 once a week', 'armGroupLabels': ['Group 1']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Placebo pill'], 'description': 'Month 1: Placebo once a week\n\nMonths 2-6: Placebo once a week', 'armGroupLabels': ['Group 2']}, {'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['cholecalciferol'], 'description': 'Daily multivitamin with 400 IU vitamin D.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Shonni J Silverberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Shonni J. Silverberg', 'investigatorAffiliation': 'Columbia University'}}}}