Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-01-29 @ 7:40 AM
Study NCT ID:
NCT02962102
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002112', 'term': 'Calcifediol'}, {'id': 'D002117', 'term': 'Calcitriol'}], 'ancestors': [{'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'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'}, {'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deleaf@bwh.harvard.edu', 'phone': '617-525-7612', 'title': 'Dr. David Leaf', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limited sample size and AKI event rate'}}, 'adverseEventsModule': {'timeFrame': '7 days for hypercalcemia and 28 days for all-cause mortality', 'eventGroups': [{'id': 'EG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4\n\nCalcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 1, 'seriousNumAtRisk': 51, 'deathsNumAffected': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg PO/NGT/OGT daily x 5 days\n\nCalcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 1, 'seriousNumAtRisk': 50, 'deathsNumAffected': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) daily x 5', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypercalcemia', 'notes': 'Serum calcium \\>10.7 mg/dl within 7 days following randomization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Death Within 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4\n\nCalcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4'}, {'id': 'OG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg PO/NGT/OGT daily x 5 days\n\nCalcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) daily x 5'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.58', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'All-cause mortality within 7 days following randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Received Renal Replacement Therapy Within 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4\n\nCalcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4'}, {'id': 'OG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg PO/NGT/OGT daily x 5 days\n\nCalcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) daily x 5'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.20', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Number of participants who received renal replacement therapy within 7 days following randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Relative Average Change in Serum Creatinine From Day 0 to Days 1-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4\n\nCalcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4'}, {'id': 'OG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg PO/NGT/OGT daily x 5 days\n\nCalcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) daily x 5'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-20.7', 'upperLimit': '18.3'}, {'value': '-7.1', 'groupId': 'OG001', 'lowerLimit': '-18.1', 'upperLimit': '12.3'}, {'value': '-7.4', 'groupId': 'OG002', 'lowerLimit': '-21.5', 'upperLimit': '10.4'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.29', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '7 days', 'description': 'Average percentage change in serum creatinine assessed on days 1-7 as compared to day 0', 'unitOfMeasure': 'Relative average percent increase', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New or Worsening Stage of AKI, Defined by KDIGO Guidelines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4\n\nCalcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4'}, {'id': 'OG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg PO/NGT/OGT daily x 5 days\n\nCalcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) daily x 5'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Any of the following: 1) an increase in serum creatinine ≥50% compared to the immediate pre-randomization value; 2) new or progressive stage of oliguria; or 3) receipt of renal replacement therapy. Oliguria stages 1, 2, and 3 are defined as urine output (UOP) \\<0.5 ml/kg/h for 6-12h, \\<0.5 ml/kg/h for \\>12h, and \\<0.3 ml/kg/h for ≥24h or anuria for ≥12h, respectively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Serum Creatinine (mg/dl)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4\n\nCalcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4'}, {'id': 'OG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg PO/NGT/OGT daily x 5 days\n\nCalcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) daily x 5'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.5'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.9'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '7 days', 'description': 'Highest serum creatinine value on days 1 to 7', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '28-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4\n\nCalcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4'}, {'id': 'OG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg PO/NGT/OGT daily x 5 days\n\nCalcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) daily x 5'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'All-cause mortality assessed during the 28 days following randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU- and Hospital-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4\n\nCalcifediol: Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4'}, {'id': 'OG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg PO/NGT/OGT daily x 5 days\n\nCalcitriol: Calcitriol 4mcg PO/NGT/OGT daily x 5'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) daily x 5'}], 'classes': [{'title': 'ICU-free days', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '25'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '22'}]}]}, {'title': 'Hospital-free days', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': '28 minus the number of days in the ICU or hospital, with 0 assigned to patients who die before 28 days', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Kidney Injury - Subgroup Analysis Based on Time Zero 25-hydroxyvitamin D Level Above Versus Below the Median', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Kidney Injury - Subgroup Analysis Based on the Presence or Absence of AKI on Enrollment', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Kidney Injury - Subgroup Analysis Based on APACHE II Score on Enrollment Above Versus Below the Median', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Kidney Injury - Subgroup Analysis Based on ICU Type (Medical Versus Surgical)', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Kidney Injury - Subgroup Analysis Based on the Presence or Absence of Sepsis on Enrollment', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4\n\nCalcifediol: Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4'}, {'id': 'FG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg orally daily x 5 days\n\nCalcitriol: Calcitriol 4mcg orally daily x 5'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) orally daily x 5'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Calcifediol', 'description': 'Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4\n\nCalcifediol: Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4'}, {'id': 'BG001', 'title': 'Calcitriol', 'description': 'Calcitriol 4mcg orally daily x 5 days\n\nCalcitriol: Calcitriol 4mcg orally daily x 5'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days\n\nPlacebos: Placebo (medium chain triglyceride oil) orally daily x 5'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '72'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '74'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '71'}, {'value': '65', 'groupId': 'BG003', 'lowerLimit': '52', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline estimated glomerular filtration rate (eGFR)', 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000', 'lowerLimit': '77', 'upperLimit': '118'}, {'value': '98', 'groupId': 'BG001', 'lowerLimit': '72', 'upperLimit': '121'}, {'value': '94', 'groupId': 'BG002', 'lowerLimit': '78', 'upperLimit': '109'}, {'value': '95', 'groupId': 'BG003', 'lowerLimit': '75', 'upperLimit': '117'}]}]}], 'paramType': 'MEDIAN', 'description': 'Calculated based on the Chronic Kidney Disease-Epidemiology Collaboration equation', 'unitOfMeasure': 'ml/min/1.73m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'APACHE II score', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '30'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '31'}, {'value': '27', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '30'}, {'value': '25', 'groupId': 'BG003', 'lowerLimit': '21', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'description': 'Acute Physiology and Chronic Health Evaluation II (APACHE II), an intensive care unit severity of illness scoring system ranging from 0 to 71, with higher scores indicating more severe disease', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Invasive mechanical ventilation', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vasopressors/inotropes', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Acute kidney injury', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Defined as an increase in serum creatinine ≥0.3 mg/d within the previous 48 hours, ≥50% within the previous 7 days, or urine output ≤0.5 ml/kg/h for 6 consecutive hours', 'unitOfMeasure': 'Participants'}, {'title': 'Plasma 25-hydroxyvitamin D', 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'BG000', 'lowerLimit': '11.2', 'upperLimit': '26.0'}, {'value': '17.3', 'groupId': 'BG001', 'lowerLimit': '10.5', 'upperLimit': '28.4'}, {'value': '14.5', 'groupId': 'BG002', 'lowerLimit': '9.7', 'upperLimit': '23.0'}, {'value': '16.5', 'groupId': 'BG003', 'lowerLimit': '10.2', 'upperLimit': '26.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-25', 'size': 689513, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-07T13:32', 'hasProtocol': True}, {'date': '2018-12-25', 'size': 232999, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-12-07T13:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2016-11-03', 'resultsFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2016-11-09', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-01-05', 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Kidney Injury - Subgroup Analysis Based on Time Zero 25-hydroxyvitamin D Level Above Versus Below the Median', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days'}, {'measure': 'Kidney Injury - Subgroup Analysis Based on the Presence or Absence of AKI on Enrollment', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days'}, {'measure': 'Kidney Injury - Subgroup Analysis Based on APACHE II Score on Enrollment Above Versus Below the Median', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days'}, {'measure': 'Kidney Injury - Subgroup Analysis Based on ICU Type (Medical Versus Surgical)', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days'}, {'measure': 'Kidney Injury - Subgroup Analysis Based on the Presence or Absence of Sepsis on Enrollment', 'timeFrame': '7 days', 'description': 'Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days'}], 'primaryOutcomes': [{'measure': 'Death Within 7 Days', 'timeFrame': '7 days', 'description': 'All-cause mortality within 7 days following randomization'}, {'measure': 'Number of Participants Who Received Renal Replacement Therapy Within 7 Days', 'timeFrame': '7 days', 'description': 'Number of participants who received renal replacement therapy within 7 days following randomization'}, {'measure': 'Relative Average Change in Serum Creatinine From Day 0 to Days 1-7', 'timeFrame': '7 days', 'description': 'Average percentage change in serum creatinine assessed on days 1-7 as compared to day 0'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With New or Worsening Stage of AKI, Defined by KDIGO Guidelines', 'timeFrame': '7 days', 'description': 'Any of the following: 1) an increase in serum creatinine ≥50% compared to the immediate pre-randomization value; 2) new or progressive stage of oliguria; or 3) receipt of renal replacement therapy. Oliguria stages 1, 2, and 3 are defined as urine output (UOP) \\<0.5 ml/kg/h for 6-12h, \\<0.5 ml/kg/h for \\>12h, and \\<0.3 ml/kg/h for ≥24h or anuria for ≥12h, respectively.'}, {'measure': 'Peak Serum Creatinine (mg/dl)', 'timeFrame': '7 days', 'description': 'Highest serum creatinine value on days 1 to 7'}, {'measure': '28-day Mortality', 'timeFrame': '28 days', 'description': 'All-cause mortality assessed during the 28 days following randomization'}, {'measure': 'ICU- and Hospital-free Days', 'timeFrame': '28 days', 'description': '28 minus the number of days in the ICU or hospital, with 0 assigned to patients who die before 28 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Ill', 'Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '40924491', 'type': 'RESULT', 'citation': 'Leaf DE, Shenoy T, Zinchuk K, Gupta S, Dias JA, Sanchez-Almanzar D, Ginde AA, Athar H, Cheng C, Tamura T, Kim EY, Waikar SS. Randomized trial of activated vitamin D for acute kidney injury prevention in critically ill patients. JCI Insight. 2025 Sep 9;10(20):e193523. doi: 10.1172/jci.insight.193523. eCollection 2025 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney injury (AKI) in critically ill patients.', 'detailedDescription': 'Decreased circulating levels of active vitamin D metabolites, including 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D (1,25D), are common in critically ill patients, and lower levels are independently associated with a higher risk of acute kidney injury (AKI). Further, administration of 25D and 1,25D attenuates AKI in animal models. The purpose of this study is to assess if administration of 25D and 1,25D decreases the incidence and severity of AKI in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Admitted to the ICU within 48h prior to enrollment\n* Likely to remain in the ICU (alive) for ≥72h\n* Naso/orogastric tube or ability to swallow\n* High risk of severe AKI\n\nExclusion Criteria:\n\n* Serum total calcium \\> 9.0 mg/dl or phosphate \\> 6.0 mg/dL within previous 48h\n* Currently receiving oral calcium supplementation\n* Ingestion of vitamin D3 \\>1,000 IU/day or any 25-hydroxyvitamin D or 1,25-dihydroxyvitamin D during the previous 7 days\n* AKI stage 2 or 3 (based on KDIGO serum creatinine and/or urine output criteria)\n* History of transplantation or receiving chronic (\\>7days) of immunosuppressive medications (not including glucocorticoid steroids at a dose less than or equivalent to prednisone 20 mg/day)\n* Neutropenia in the previous 48h\n* Active primary parathyroid disease, active granulomatous disease, or symptomatic nephrolithiasis in the previous 3 months\n* Receiving cytochrome P450 inhibitors\n* Chronic Kidney Disease stage V or End Stage Renal Disease\n* Hemoglobin \\< 7 g/dL\n* GI malabsorption\n* Prisoner\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT02962102', 'acronym': 'ACTIVATE-AKI', 'briefTitle': 'Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (ACTIVATE-AKI)', 'orgStudyIdInfo': {'id': '2016P002527'}, 'secondaryIdInfos': [{'id': '5K23DK106448', 'link': 'https://reporter.nih.gov/quickSearch/5K23DK106448', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcifediol', 'description': 'Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4', 'interventionNames': ['Drug: Calcifediol']}, {'type': 'EXPERIMENTAL', 'label': 'Calcitriol', 'description': 'Calcitriol 4mcg orally daily x 5 days', 'interventionNames': ['Drug: Calcitriol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Calcifediol', 'type': 'DRUG', 'description': 'Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4', 'armGroupLabels': ['Calcifediol']}, {'name': 'Calcitriol', 'type': 'DRUG', 'description': 'Calcitriol 4mcg orally daily x 5', 'armGroupLabels': ['Calcitriol']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo (medium chain triglyceride oil) orally daily x 5', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'David E Leaf, MD, MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Leaf', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine, Harvard Medical School', 'investigatorFullName': 'David Leaf', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}