Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-02-08 @ 5:45 AM
Study NCT ID:
NCT00748618
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2008-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D Replacement After Kidney Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fangyu@unmc.edu', 'phone': '(402) 559-9436', 'title': 'Fang Yu', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Vitamin Treatment', 'description': 'Standard vitamin treatment\n\nvitamin D3: Participants receive 10,000 I.U./wk of vitamin D3 orally for 6 months', 'otherNumAtRisk': 46, 'otherNumAffected': 1, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '50,000 I.U. of Vitamin D3', 'description': '50,000 I.U. of vitamin D3\n\nvitamin D3: Participants receive 50,000 I.U./wk of vitamin D3 orally for 6 months', 'otherNumAtRisk': 44, 'otherNumAffected': 2, 'seriousNumAtRisk': 44, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Elevated calcium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Viral gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reoccurring UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enteric Conversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Vitamin Treatment', 'description': 'Standard vitamin treatment\n\nvitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months'}, {'id': 'OG001', 'title': '50,000 I.U. of Vitamin D3', 'description': '50,000 I.U. of vitamin D3\n\nvitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '-10', 'upperLimit': '32'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '-9', 'upperLimit': '61'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The 6 month change (6 month - Baseline) was compared between the two treatment arms of vitamin D supplements for normalizing vitamin D concentrations. Higher change values indicate improvement in vitamin D levels.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had baseline and 6 month 25-hydroxy Vitamin D levels measured'}, {'type': 'SECONDARY', 'title': 'The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Vitamin Treatment', 'description': 'Standard vitamin treatment\n\nvitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months'}, {'id': 'OG001', 'title': '50,000 I.U. of Vitamin D3', 'description': '50,000 I.U. of vitamin D3\n\nvitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-120.6', 'upperLimit': '81.0'}, {'value': '-9.0', 'groupId': 'OG001', 'lowerLimit': '-94.0', 'upperLimit': '200.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and 6 months', 'description': 'The 6 month change (6 month - Baseline) in parathyroid hormone concentration was compared between the two treatment arms.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Available data from patients who had baseline and 6 month parathyroid hormone concentration levels obtained.'}, {'type': 'SECONDARY', 'title': 'The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Vitamin Treatment', 'description': 'Standard vitamin treatment\n\nvitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months'}, {'id': 'OG001', 'title': '50,000 I.U. of Vitamin D3', 'description': '50,000 I.U. of vitamin D3\n\nvitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.45', 'groupId': 'OG000', 'lowerLimit': '-1215.4', 'upperLimit': '1906.7'}, {'value': '-1.95', 'groupId': 'OG001', 'lowerLimit': '-1652.7', 'upperLimit': '798.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The 6 month change (6 month - Baseline) in spot urine protein-creatinine ratio was compared between the two treatment arms.', 'unitOfMeasure': 'mg/mmol', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Available data from patients who had baseline and 6 month spot urine protein-creatinine ratio levels obtained.'}, {'type': 'SECONDARY', 'title': 'The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Vitamin Treatment', 'description': 'Standard vitamin treatment\n\nvitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months'}, {'id': 'OG001', 'title': '50,000 I.U. of Vitamin D3', 'description': '50,000 I.U. of vitamin D3\n\nvitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-13.5', 'upperLimit': '18.4'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '-42.2', 'upperLimit': '51.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The 6 month change in High-sensitivity C-reactive protein (HsCRP) levels was compared between the two treatment arms.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Available data from patients who had baseline and 6 month HsCRP levels obtained'}, {'type': 'SECONDARY', 'title': 'The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Vitamin Treatment', 'description': 'Standard vitamin treatment\n\nvitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months'}, {'id': 'OG001', 'title': '50,000 I.U. of Vitamin D3', 'description': '50,000 I.U. of vitamin D3\n\nvitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-7.2', 'upperLimit': '4.3'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The 6 month change (6 month - Baseline) in insulin resistance was assessed with HOMA-IR (Homeostatic Model Assessment-Insulin Resistance), which is calculated by fasting glucose (mg/dL) X fasting insulin (mU/L) /405.', 'unitOfMeasure': '(microU/L) x (nmol/L)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Available data from patients who had baseline and 6 month HOMA-IR levels obtained.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Vitamin Treatment', 'description': 'Standard vitamin treatment\n\nvitamin D3: Participants receive 10,000 I.U./wk of vitamin D3 orally for 6 months'}, {'id': 'FG001', 'title': '50,000 I.U. of Vitamin D3', 'description': '50,000 I.U. of vitamin D3\n\nvitamin D3: Participants receive 50,000 I.U./wk of vitamin D3 orally for 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '165 subjects were screened, and 93 subjects were eligible and were randomized to treatments. Three patients voluntarily withdrew consent immediately following randomization. A total of 90 subjects received treatments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Vitamin Treatment', 'description': 'Standard vitamin treatment\n\nvitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months'}, {'id': 'BG001', 'title': '50,000 I.U. of Vitamin D3', 'description': '50,000 I.U. of vitamin D3\n\nvitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '52.1', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vitamin D Concentration', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '26.3', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '26.7', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2008-09-04', 'resultsFirstSubmitDate': '2023-06-19', 'studyFirstSubmitQcDate': '2008-09-05', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-05', 'studyFirstPostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.', 'timeFrame': 'Baseline and 6 months', 'description': 'The 6 month change (6 month - Baseline) was compared between the two treatment arms of vitamin D supplements for normalizing vitamin D concentrations. Higher change values indicate improvement in vitamin D levels.'}], 'secondaryOutcomes': [{'measure': 'The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.', 'timeFrame': 'baseline and 6 months', 'description': 'The 6 month change (6 month - Baseline) in parathyroid hormone concentration was compared between the two treatment arms.'}, {'measure': 'The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.', 'timeFrame': '6 months', 'description': 'The 6 month change (6 month - Baseline) in spot urine protein-creatinine ratio was compared between the two treatment arms.'}, {'measure': 'The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.', 'timeFrame': 'Baseline and 6 months', 'description': 'The 6 month change in High-sensitivity C-reactive protein (HsCRP) levels was compared between the two treatment arms.'}, {'measure': 'The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'The 6 month change (6 month - Baseline) in insulin resistance was assessed with HOMA-IR (Homeostatic Model Assessment-Insulin Resistance), which is calculated by fasting glucose (mg/dL) X fasting insulin (mU/L) /405.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney transplantation (KTX)', 'Vitamin D deficiency', 'Cardiovascular Disease (CVD)', 'Vascular risk', 'Parathyroid hormone (PTH)', 'Carotid intima media thickness (CIMT)', 'Insulin resistance (IR)'], 'conditions': ['Kidney Transplantation', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'Vitamin D deficiency accelerates vascular risk progression after kidney transplant.', 'detailedDescription': 'This trial will assess the following aims:\n\n1. Time to plateau vitamin D concentrations after initiating vitamin D supplements\n2. Safety of vitamin D replacement based on serum and urine calcium\n3. Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone\n4. Effect of vitamin D on markers of insulin resistance and inflammation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney transplant more than 6 months ago\n* 19 years or older\n* 25-hydroxy vitamin D ≤35 ng/ml\n\nExclusion Criteria:\n\n* Estimated Glomerular filtration rate (GFR) \\<30 ml/min/1.73m²\n* Previous small bowel or lung transplant\n* Pancreas transplant less than 6 months ago\n* Cancer or any condition that would change their weight dramatically in the near future such as malabsorption\n* Willing to return for testing every two months\n* Women who are pregnant or \\< 6 weeks postpartum\n* Calcium \\> 10.5 mg/dl\n* Phosphate \\> 4.8 mg/dl\n* Drinking more than 2 alcohol drinks a day or 14 drinks per week\n* History of parathyroid surgery\n* Known granulomatous disease\n* Taking any seizure medication that affects vitamin D\n* Taking Zemplar ® and/or Rocaltrol ®\n* History of kidney stones in the past 20 years\n* Not on a stable dose of bisphosphonate for the past three months\n* Planning on a pancreas transplant within the next year\n* In any other research study'}, 'identificationModule': {'nctId': 'NCT00748618', 'briefTitle': 'Vitamin D Replacement After Kidney Transplant', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Vitamin D Replacement After Kidney Transplant', 'orgStudyIdInfo': {'id': '0382-08-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard vitamin treatment', 'description': '10,000 I.U. of vitamin D3 weekly', 'interventionNames': ['Dietary Supplement: Standard vitamin D3 treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': '50,000 I.U. of vitamin D3', 'description': '50,000 I.U. of vitamin D3 weekly', 'interventionNames': ['Dietary Supplement: High dose vitamin D3 treatment']}], 'interventions': [{'name': 'Standard vitamin D3 treatment', 'type': 'DIETARY_SUPPLEMENT', 'description': '10,000 I.U./wk of vitamin D3 orally for 6 months', 'armGroupLabels': ['Standard vitamin treatment']}, {'name': 'High dose vitamin D3 treatment', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['D3, vitamin D'], 'description': '50,000 I.U./wk of vitamin D3 orally for 6 months', 'armGroupLabels': ['50,000 I.U. of vitamin D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Jennifer L Larsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}