Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-20 @ 2:10 AM
Study NCT ID:
NCT02925195
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2016-10-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Individualized Response to Vitamin D Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IDeBoer@Nephrology.washington.edu', 'phone': '206-616-5403', 'title': 'Dr. Ian de Boer', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Active Treatment', 'description': 'Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily', 'otherNumAtRisk': 499, 'deathsNumAtRisk': 499, 'otherNumAffected': 55, 'seriousNumAtRisk': 499, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 16, 'seriousNumAtRisk': 167, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal, connective tissue, and bone disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasms benign, malignant, and unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary tract disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic, and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diverticulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum 1,25(OH)2D Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '16', 'groupId': 'OG000'}, {'value': '-1', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Serum PTH Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'spread': '16', 'groupId': 'OG000'}, {'value': '2', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'spread': '18', 'groupId': 'OG000'}, {'value': '-4', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Urine Calcium Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '83', 'groupId': 'OG000'}, {'value': '1', 'spread': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Urine calcium excretion estimated as spot urine calcium-creatinine ratio', 'unitOfMeasure': 'mg per g of creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Calcium Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Treatment', 'description': 'Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '499'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '453'}, {'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '666', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Treatment', 'description': 'Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '8', 'groupId': 'BG000'}, {'value': '72', 'spread': '8', 'groupId': 'BG001'}, {'value': '72', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic White', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}, {'title': 'Chinese', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-05', 'size': 880364, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-18T13:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 666}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2016-10-03', 'resultsFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-11', 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum 1,25(OH)2D Concentration', 'timeFrame': '16 weeks'}, {'measure': 'Change in Serum PTH Concentration', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': '16 weeks'}, {'measure': 'Change in Urine Calcium Excretion', 'timeFrame': '16 weeks', 'description': 'Urine calcium excretion estimated as spot urine calcium-creatinine ratio'}, {'measure': 'Change in Serum Calcium Concentrations', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'cardiovascular disease', 'MESA', 'genetics', 'pharmacogenetics', 'blood pressure', 'biomarkers'], 'conditions': ['Characteristics That Modify the Response to Cholecalciferol Treatment']}, 'referencesModule': {'references': [{'pmid': '34849546', 'type': 'RESULT', 'citation': 'Hsu S, Prince DK, Williams K, Allen NB, Burke GL, Hoofnagle AN, Li X, Liu KJ, McClelland RL, Michos ED, Psaty BM, Shea SJ, Rice KM, Rotter JI, Siscovick D, Tracy RP, Watson KE, Kestenbaum BR, de Boer IH. Clinical and biomarker modifiers of vitamin D treatment response: the Multi-Ethnic Study of Atherosclerosis. Am J Clin Nutr. 2022 Mar 4;115(3):914-924. doi: 10.1093/ajcn/nqab390.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine individual-level genetic and metabolic characteristics that modify the response to cholecalciferol treatment.\n\nThis study is double blind, parallel design, randomized clinical trial that will assess genetic and metabolic characteristics that modify the response to cholecalciferol treatment. . Eligible participants will be randomly assigned to receive cholecalciferol treatment (2,000 international units of cholecalciferol daily by mouth) or placebo in a 3:1 ratio for a total duration of 16-weeks. The planned sample size is 1,600. The primary aim of this study is to identify genetic polymorphisms, clinical characteristics, and biomarkers that modify the biologic response to vitamin D3 treatment, assessed by changes in serum concentrations of parathyroid hormone (PTH) and 1,25(OH)2D and urine calcium excretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1,600 participants from the Multi-Ethnic Study of Atherosclerosis (MESA) study who are returning for their scheduled 6th MESA study visit.\n\nParticipants will be recruited from four field centers: Wake Forest University, Winston-Salem, NC; Columbia University, New York, NY; Northwestern University, Evanston, IL; and Johns Hopkins University, Baltimore, MD.\n\nExclusion Criteria:\n\n1. Current use of \\>1,000 international units (IU) of cholecalciferol daily\n2. Current use of any activated vitamin D product (calcitriol, paricalcitol, hectorol)\n3. Known history of allergy or adverse reaction to vitamin D treatment\n4. Known clinical history of primary hyperparathyroidism\n5. Known clinical history of kidney stones within the previous 5 years\n6. Current participation in another interventional study\n7. Inability to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT02925195', 'acronym': 'INVITE', 'briefTitle': 'Individualized Response to Vitamin D Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Multi Ethnic Study of Atherosclerosis Individualized Response to Vitamin D Treatment Study', 'orgStudyIdInfo': {'id': 'STUDY00001485'}, 'secondaryIdInfos': [{'id': 'R01HL096875', 'link': 'https://reporter.nih.gov/quickSearch/R01HL096875', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'cholecalciferol (vitamin D3) 2000 IU capsules daily', 'armGroupLabels': ['Active Treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Univeristy', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Ian de Boer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Bryan Kestenbaum', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Medicine/Nephrology', 'investigatorFullName': 'Ian deBoer', 'investigatorAffiliation': 'University of Washington'}}}}