Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-31 @ 4:13 AM
Study NCT ID:
NCT02881957
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2016-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypovitaminosis D in Neurocritical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'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'}]}, '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': 'michael.karsy@hsc.utah.edu', 'phone': '801-581-6908', 'title': 'Dr. Michael Karsy', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored until patient discharge from the hospital.', 'description': 'Catalog of CTCAE grade 3 or 4 adverse events directly related to study drug. Only adverse events or severe adverse events, related specifically to the study drug, were monitored. No serious events in any organ system were identified in this study and thus the listing of only the main heading for Serious Adverse Events and Other (Not Including Serious) Adverse Events reflects this, which is accurate and appropriate.', 'eventGroups': [{'id': 'EG000', 'title': 'Vitamin D3', 'description': 'Patient demographics of patients receiving study drug', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 0, 'seriousNumAtRisk': 134, 'deathsNumAffected': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patient demographics of patients receiving placebo', 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'deathsNumAffected': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intent-to-treat Hospital Length-of-stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3', 'description': 'Patient demographics of patients receiving study drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient demographics of patients receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients as randomized (e.g., intent-to-treat) using a p\\<0.05 as significant. Adverse events were monitored until discharge.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Until discharge', 'description': 'Intent-to-treat hospital length-of-stay', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'As-treated Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3', 'description': 'Patient demographics of patients receiving study drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient demographics of patients receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Until discharge', 'description': 'Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients after randomization, factoring excluded patients (e.g., as-treated) using a p\\<0.05 as significant.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intent-to-treat ICU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3', 'description': 'Patient demographics of patients receiving study drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient demographics of patients receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '9.8', 'groupId': 'OG000'}, {'value': 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'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Until discharge', 'description': 'Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization but excluding patients who did not receive treatment (e.g., as-treated) using a p\\<0.05 as significant.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In-hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3', 'description': 'Patient 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demographics of patients receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Adverse events were monitored until patient discharge from the hospital.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until discharge', 'description': 'The occurrence of patients who suffered mortality, adverse events or severe adverse events, related specifically to the study drug was monitored. Severe adverse events are defined using common terminology criteria for adverse events (CTCAE) grade 3 or higher specific to vitamin D from time of study drug administration to discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3', 'description': 'Patient demographics of patients receiving study drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient demographics of patients receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Adverse events were monitored until patient discharge from the hospital.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until discharge', 'description': 'Diagnosis of sepsis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3', 'description': 'Patient demographics of patients receiving study drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient demographics of patients receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Adverse events were monitored until patient discharge from the hospital.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until discharge', 'description': 'Pneumonia diagnosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Urinary Tract Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3', 'description': 'Patient demographics of patients receiving study drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient demographics of patients receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Adverse events were monitored until patient discharge from the hospital.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until discharge', 'description': 'Urinary tract infection diagnosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Deep Vein Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin D3', 'description': 'Patient demographics of patients receiving study drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patient demographics of patients receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Adverse events were monitored until patient discharge from the hospital.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until discharge', 'description': 'Deep vein thrombosis diagnosis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo control (simple oral syrup)\n\nPlacebo: Oral syrup placebo'}, {'id': 'FG001', 'title': 'Vitamin D3', 'description': 'Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)\n\nCholecalciferol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Comfort care', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Concurrent trial enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Discharged within 48 hours', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vitamin D3', 'description': 'Patient demographics of patients receiving study drug'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patient demographics of patients receiving placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'spread': '17.5', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '16.8', 'groupId': 'BG001'}, {'value': '54.0', 'spread': '17.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-30', 'size': 514312, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-02T22:03', 'hasProtocol': True}, {'date': '2017-09-13', 'size': 998867, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-28T21:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2016-08-24', 'resultsFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-02', 'studyFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intent-to-treat Hospital Length-of-stay', 'timeFrame': 'Until discharge', 'description': 'Intent-to-treat hospital length-of-stay'}, {'measure': 'As-treated Hospital Length of Stay', 'timeFrame': 'Until discharge', 'description': 'Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients after randomization, factoring excluded patients (e.g., as-treated) using a p\\<0.05 as significant.'}], 'secondaryOutcomes': [{'measure': 'Intent-to-treat ICU Length of Stay', 'timeFrame': 'Until discharge', 'description': 'Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization (e.g., intent-to-treat) using a p\\<0.05 as significant.'}, {'measure': 'As-treated ICU Length of Stay', 'timeFrame': 'Until discharge', 'description': 'Two-sided t-test evaluated comparing length of stay within the ICU specifically in vitamin D3 vs. placebo treated patients utilizing patients after randomization but excluding patients who did not receive treatment (e.g., as-treated) using a p\\<0.05 as significant.'}, {'measure': 'In-hospital Mortality', 'timeFrame': 'Until discharge', 'description': 'In-hospital mortality'}, {'measure': 'Number of Participants With Study Drug Related Adverse Events', 'timeFrame': 'Until discharge', 'description': 'The occurrence of patients who suffered mortality, adverse events or severe adverse events, related specifically to the study drug was monitored. Severe adverse events are defined using common terminology criteria for adverse events (CTCAE) grade 3 or higher specific to vitamin D from time of study drug administration to discharge.'}, {'measure': 'Number of Participants With Sepsis', 'timeFrame': 'Until discharge', 'description': 'Diagnosis of sepsis'}, {'measure': 'Number of Participants With Pneumonia', 'timeFrame': 'Until discharge', 'description': 'Pneumonia diagnosis'}, {'measure': 'Number of Participants With Urinary Tract Infection', 'timeFrame': 'Until discharge', 'description': 'Urinary tract infection diagnosis'}, {'measure': 'Number of Participants With Deep Vein Thrombosis', 'timeFrame': 'Until discharge', 'description': 'Deep vein thrombosis diagnosis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['critical illness', 'craniocerebral trauma', 'intracranial aneurysm', 'spinal cord injuries', 'seizures', 'meningitis', 'stroke', 'vitamin d deficiency', 'cholecalciferol', 'intracranial hemorrhages'], 'conditions': ['Craniocerebral Trauma', 'Intracranial Aneurysm', 'Brain Neoplasms', 'Spinal Cord Injuries', 'Seizures', 'Meningitis', 'Stroke', 'Intracranial Hemorrhages', 'Critical Illness', 'Vitamin d Deficiency']}, 'referencesModule': {'references': [{'pmid': '27367248', 'type': 'BACKGROUND', 'citation': 'Guan J, Karsy M, Brock AA, Eli IM, Ledyard HK, Hawryluk GWJ, Park MS. A prospective analysis of hypovitaminosis D and mortality in 400 patients in the neurocritical care setting. J Neurosurg. 2017 Jul;127(1):1-7. doi: 10.3171/2016.4.JNS16169. Epub 2016 Jul 1.'}, {'pmid': '31518987', 'type': 'BACKGROUND', 'citation': 'Carter BS, Barker FG. Editorial. Choices in clinical trial design. J Neurosurg. 2019 Sep 13;133(4):1100-1102. doi: 10.3171/2019.7.JNS183276. Print 2020 Oct 1. No abstract available.'}, {'pmid': '31518978', 'type': 'RESULT', 'citation': 'Karsy M, Guan J, Eli I, Brock AA, Menacho ST, Park MS. The effect of supplementation of vitamin D in neurocritical care patients: RandomizEd Clinical TrIal oF hYpovitaminosis D (RECTIFY). J Neurosurg. 2019 Sep 13;133(4):1103-1112. doi: 10.3171/2018.11.JNS182713. Print 2020 Oct 1.'}], 'seeAlsoLinks': [{'url': 'http://medicine.utah.edu/neurosurgery/', 'label': 'University of Utah, Department of Neurosurgery'}]}, 'descriptionModule': {'briefSummary': 'Vitamin D has been shown to impact prognosis in a variety of retrospective and randomized clinical trials within an intensive care unit (ICU) environment. Despite these findings, there have been no studies examining the impact of hypovitaminosis D in specialized neurocritical care units (NCCU). Given the often significant differences in the management of patients in NCCU and more generalized intensive care units there is a need for further inquiries into the impact of low vitamin D levels in this specific environment. This study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin D supplementation in the emergent NCCU patient population. The primary outcome will involve length-of-stay for emergent neurocritical care patients. Various secondary outcomes, including in-hospital mortality, ICU length-of-stay, Glasgow Outcome Score on discharge, complications and quality-of-life metrics. Patients will be followed for 6 months post-discharge.', 'detailedDescription': "Vitamin D has been shown as an important marker of prognosis in a variety of clinical settings, including overall mortality, acute respiratory distress syndrome (ARDS), infection/sepsis, asthma, cardiovascular disease, diabetes, and pediatric/medical/surgical intensive care unit outcomes. Vitamin D not only plays a role in bone maintenance, but also a variety of extra-axial functions including immune-dysregulation and systemic inflammation. In addition, a number of randomized clinical trials support the supplementation of vitamin D as improving outcome in critical care patients. While the evaluation of vitamin D levels remains a standard-of-care at our institution, the widespread use of vitamin D monitoring and impact on neurocritical care patients remains limited. The investigators' recent prospective observational study of vitamin D levels in neurocritical patients showed that deficiency (\\<20ng/dL) was highly associated with prolonged hospital stay and increased in-hospital mortality for emergent patients. Moreover, a number of limitations arise from this study due to its observational nature. This study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin D supplementation in the neurocritical care patient population. Patients admitted to the neurocritical care unit for emergent cases and with vitamin D deficiency (\\<20ng/dL) will undergo vitamin D serum draw on admission and be randomized to receive cholecalciferol/vitamin D3 supplementation (540,000 IU once orally) or placebo. The primary outcome measured will be hospital length-of-stay. Secondary outcomes will include length of ICU course, complications, medication adverse events, discharge Glasgow Outcome Score, in-hospital and 30-day mortality, as well as quality-of-life. Power analysis estimates 198 patients will be needed for each subgroup to determine a 2 day difference in length-of-stay, and the study plans to recruit 218 patients per treatment arm to account for dropout, which will take approximately 6-9 months to recruit. Interim analysis and safety monitoring will be performed. The investigators hypothesize that vitamin D supplementation may make a significant impact on reducing morbidity and mortality in the neurocritical care population. The possibility of reducing hospital length of stay and mortality from a simple, safe, and cost-effective intervention such as vitamin D supplementation may be a useful adjuvant treatment in the neurocritical care population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years of age\n* Patients admitted to the neurosurgery or neurology services\n* Patients admitted to a critical care unit\n* Informed consent\n* Expected to stay in the ICU for 48 hours or more\n* Vitamin D deficiency (\\<20ng/mL)\n\nExclusion Criteria:\n\n* Patients where a vitamin D level was not drawn within 48 hours of admission\n* Patients not randomized within 48 hours of admission\n* Readmitted patients to the critical care unit\n* Lack of informed consent\n* Prior supplementation with vitamin D\n* Severely impaired gastrointestinal function\n* Other trial participation\n* Pregnant or lactating women\n* Hypercalcemia (total calcium of \\>10.6 mg/dL or ionized serum calcium of \\>5.4 mg/dL\n* Tuberculosis history or clinical exam\n* Sarcoidosis history or clinical exam\n* Nephrolithiasis within the prior year\n* Patients not deemed suitable for study participation (ie, psychiatric disease, living remotely from the clinic, or prisoner status)\n* Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT02881957', 'briefTitle': 'Hypovitaminosis D in Neurocritical Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Randomized Clinical Trial of Hypovitaminosis D Treatment in the Neurocritical Care Unit', 'orgStudyIdInfo': {'id': 'IRB_00091541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo control (simple oral syrup)', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D3', 'description': 'Cholecalciferol/Vitamin D3 (540,000 IU orally or by feeding tube once)', 'interventionNames': ['Drug: Cholecalciferol']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG', 'otherNames': ['vitamin D3'], 'armGroupLabels': ['Vitamin D3']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oral syrup placebo', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Michael Karsy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah, Department of Neurosurgery, Salt Lake City, UT'}, {'name': 'Min S Park, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Utah, Department of Neurosurgery, Salt Lake City, UT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Ph.D.', 'investigatorFullName': 'Michael Karsy, MD, PhD, MSC', 'investigatorAffiliation': 'University of Utah'}}}}