Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02416193
Status:
TERMINATED
Last Update Posted:
2020-10-23
First Post:
2015-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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': 'mbyrn@luc.edu', 'phone': '(773) 508-8973', 'title': 'Mary Byrn, R.N., Ph.D.', 'organization': 'Loyola University Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The trial experienced early termination leading to small numbers of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 20 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 12, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 9, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cold virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Short menstrual period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Menstrual cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arm pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataracts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dark stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Strep throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Goiter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arhritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor vehicle accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Letter-Number Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months'}, {'id': 'OG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '9.13', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '9.00', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'The the Letter-Number Sequencing Test (from the Wechsler Adult Intelligence Scale-III assessment) is an assessment of working memory. Scores on the assessment are standardized as scaled scores with a mean of 10 and standard deviation of 3 (μ = 10, SD = 3) using age adjusted normative data provided by Pearson assessments (https://www.pearsonassessments.com/). A scaled score indicates the number of standard deviations away from the mean. A scaled score of 10 is equal to the mean. Scaled scores below 10 indicate performance is lower than average, and scaled scores higher than 10 indicate performance is higher than average. Higher scaled scores indicate better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.'}, {'type': 'PRIMARY', 'title': 'Controlled Oral Word Association Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months'}, {'id': 'OG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'The Controlled Oral Word Association Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.'}, {'type': 'PRIMARY', 'title': 'Stroop Interference Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months'}, {'id': 'OG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'The Stroop Interference Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.'}, {'type': 'PRIMARY', 'title': 'Symbol-Digit Modality Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months'}, {'id': 'OG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'The Symbol-Digit Modality Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.'}, {'type': 'PRIMARY', 'title': 'Trail Making Test Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months'}, {'id': 'OG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'The Trail Making Test Part B is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Hopkins Verbal Learning Total Recall Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months'}, {'id': 'OG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '38.07', 'spread': '8.92', 'groupId': 'OG000'}, {'value': '39.57', 'spread': '11.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'The Hopkins Verbal Learning Total Recall Test is an assessment of memory. Scores are standardized as T-scores (μ = 50, SD = 10) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. T-scores below 50 indicate performance is lower than average, and T-scores above 50 indicate performance is higher than average. Higher T-scores indicate better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Semantic Fluency Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months'}, {'id': 'OG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 Weeks', 'description': 'The Semantic Fluency Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months'}, {'id': 'FG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment for this study took place at Loyola University Medical Center (Maywood, IL) between September 2015 and June 2018', 'preAssignmentDetails': 'Fifty-six participants consented to participate in the study. Among these individuals, 26 (46.43%) were not randomized and were excluded from continuing their participation in the study because the medical monitor determined they did not meet study inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months'}, {'id': 'BG001', 'title': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.62', 'spread': '10.14', 'groupId': 'BG000'}, {'value': '55.80', 'spread': '9.68', 'groupId': 'BG001'}, {'value': '55.71', 'spread': '9.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years of education', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '15'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '16'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '13', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total vitamin D level', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '25'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '28'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '17', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Nanograms per milliliter (ng/mL)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum vitamin D3 level', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '25'}, {'value': '24', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '28'}, {'value': '22', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Nanograms per milliliter (ng/mL)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '40.44', 'spread': '9.48', 'groupId': 'BG000'}, {'value': '34.20', 'spread': '5.05', 'groupId': 'BG001'}, {'value': '37.32', 'spread': '8.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per meter squared (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Martial status', 'classes': [{'categories': [{'title': 'Currently married', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Separated', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Widowed', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Divorced', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Never married', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Season of first dose of the study drug', 'classes': [{'categories': [{'title': 'Fall', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Winter', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Spring', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Summer', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '134.73', 'spread': '16.33', 'groupId': 'BG000'}, {'value': '131.13', 'spread': '16.95', 'groupId': 'BG001'}, {'value': '132.93', 'spread': '16.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '73.47', 'spread': '10.99', 'groupId': 'BG000'}, {'value': '72.93', 'spread': '10.79', 'groupId': 'BG001'}, {'value': '73.20', 'spread': '10.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate', 'classes': [{'categories': [{'measurements': [{'value': '73.27', 'spread': '12.67', 'groupId': 'BG000'}, {'value': '76.00', 'spread': '12.86', 'groupId': 'BG001'}, {'value': '74.63', 'spread': '12.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats per minute (BPM)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.10', 'groupId': 'BG000', 'lowerLimit': '6.30', 'upperLimit': '7.50'}, {'value': '7.20', 'groupId': 'BG001', 'lowerLimit': '6.20', 'upperLimit': '7.80'}, {'value': '7.15', 'groupId': 'BG002', 'lowerLimit': '6.30', 'upperLimit': '7.70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Glucose', 'classes': [{'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000', 'lowerLimit': '95', 'upperLimit': '160'}, {'value': '142', 'groupId': 'BG001', 'lowerLimit': '116', 'upperLimit': '214'}, {'value': '134', 'groupId': 'BG002', 'lowerLimit': '107', 'upperLimit': '165'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Millimoles per liter (mmol/L)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Calcium', 'classes': [{'categories': [{'measurements': [{'value': '9.40', 'groupId': 'BG000', 'lowerLimit': '9.30', 'upperLimit': '9.60'}, {'value': '9.60', 'groupId': 'BG001', 'lowerLimit': '9.40', 'upperLimit': '9.90'}, {'value': '9.50', 'groupId': 'BG002', 'lowerLimit': '9.30', 'upperLimit': '9.70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'groupId': 'BG000', 'lowerLimit': '0.66', 'upperLimit': '0.90'}, {'value': '0.83', 'groupId': 'BG001', 'lowerLimit': '0.70', 'upperLimit': '0.88'}, {'value': '0.79', 'groupId': 'BG002', 'lowerLimit': '0.69', 'upperLimit': '0.88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Activity level', 'classes': [{'categories': [{'title': 'Insufficiently active', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Moderately active', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Sufficiently active', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline physical activity was assessed using the Godin Leisure-Time Exercise Questionnaire. The measure of physical activity ranges from 0 to infinity points. Scores less than 14 points on this assessment indicate insufficient physical activity while scores of 24 or higher indicate sufficient physical activity; other scores are categorized as being moderately active.', 'unitOfMeasure': 'Participants'}, {'title': 'WRAT-IV Reading Score', 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'BG000', 'lowerLimit': '-1.20', 'upperLimit': '-0.33'}, {'value': '-0.93', 'groupId': 'BG001', 'lowerLimit': '-1.20', 'upperLimit': '-0.20'}, {'value': '-0.97', 'groupId': 'BG002', 'lowerLimit': '-1.20', 'upperLimit': '-0.33'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Wide Range Achievement Test (WRAT-IV) reading subtest score is a 55-item assessment of letter and word decoding through letter identification and word recognition. Scores are standardized as z-scores using age-adjusted norms provided by Pearson Assessments (https://www.pearsonassessments.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Patient Health Questionnaire-9', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '7'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Patient Health Questionnaire-9 is an assessment of depression. Scores range from 1 to 27 points with higher scores indicating worse mood.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CES-D Score', 'classes': [{'categories': [{'measurements': [{'value': '7.13', 'spread': '3.46', 'groupId': 'BG000'}, {'value': '9.73', 'spread': '4.80', 'groupId': 'BG001'}, {'value': '8.43', 'spread': '4.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Center for Epidemiologic Studies Depression (CES-D) assessment measures mood. Scores range from 0 to 60 points with higher scores indicating worse symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The baseline analysis population comprises all individuals who consented to participate and took at least one dose of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-01', 'size': 286820, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-02T13:33', 'hasProtocol': True}, {'date': '2018-02-21', 'size': 208987, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-11-02T13:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'the study was halted prematurely due to slow recruitment and expiration of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2015-04-06', 'resultsFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-30', 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Letter-Number Sequencing', 'timeFrame': '13 weeks', 'description': 'The the Letter-Number Sequencing Test (from the Wechsler Adult Intelligence Scale-III assessment) is an assessment of working memory. Scores on the assessment are standardized as scaled scores with a mean of 10 and standard deviation of 3 (μ = 10, SD = 3) using age adjusted normative data provided by Pearson assessments (https://www.pearsonassessments.com/). A scaled score indicates the number of standard deviations away from the mean. A scaled score of 10 is equal to the mean. Scaled scores below 10 indicate performance is lower than average, and scaled scores higher than 10 indicate performance is higher than average. Higher scaled scores indicate better performance.'}, {'measure': 'Controlled Oral Word Association Test', 'timeFrame': '13 Weeks', 'description': 'The Controlled Oral Word Association Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.'}, {'measure': 'Stroop Interference Test', 'timeFrame': '13 Weeks', 'description': 'The Stroop Interference Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.'}, {'measure': 'Symbol-Digit Modality Test', 'timeFrame': '13 Weeks', 'description': 'The Symbol-Digit Modality Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.'}, {'measure': 'Trail Making Test Part B', 'timeFrame': '13 Weeks', 'description': 'The Trail Making Test Part B is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.'}], 'secondaryOutcomes': [{'measure': 'Hopkins Verbal Learning Total Recall Test', 'timeFrame': '13 weeks', 'description': 'The Hopkins Verbal Learning Total Recall Test is an assessment of memory. Scores are standardized as T-scores (μ = 50, SD = 10) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. T-scores below 50 indicate performance is lower than average, and T-scores above 50 indicate performance is higher than average. Higher T-scores indicate better performance.'}, {'measure': 'Semantic Fluency Test', 'timeFrame': '13 Weeks', 'description': 'The Semantic Fluency Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Cognition', 'Functioning'], 'conditions': ['Diabetes', 'Executive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '25031883', 'type': 'BACKGROUND', 'citation': 'Lee JH, Choi Y, Jun C, Hong YS, Cho HB, Kim JE, Lyoo IK. Neurocognitive changes and their neural correlates in patients with type 2 diabetes mellitus. Endocrinol Metab (Seoul). 2014 Jun;29(2):112-21. doi: 10.3803/EnM.2014.29.2.112.'}, {'pmid': '24898849', 'type': 'BACKGROUND', 'citation': 'Smith MA, Else JE, Paul L, Foster JK, Walker M, Wesnes KA, Riby LM. Functional Living in Older Adults With Type 2 Diabetes: Executive Functioning, Dual Task Performance, and the Impact on Postural Stability and Motor Control. J Aging Health. 2014 Aug;26(5):841-859. doi: 10.1177/0898264314534896. Epub 2014 Jun 4.'}, {'pmid': '25098535', 'type': 'BACKGROUND', 'citation': 'Littlejohns TJ, Henley WE, Lang IA, Annweiler C, Beauchet O, Chaves PH, Fried L, Kestenbaum BR, Kuller LH, Langa KM, Lopez OL, Kos K, Soni M, Llewellyn DJ. Vitamin D and the risk of dementia and Alzheimer disease. Neurology. 2014 Sep 2;83(10):920-8. doi: 10.1212/WNL.0000000000000755. Epub 2014 Aug 6.'}, {'pmid': '18056830', 'type': 'BACKGROUND', 'citation': 'McCann JC, Ames BN. Is there convincing biological or behavioral evidence linking vitamin D deficiency to brain dysfunction? FASEB J. 2008 Apr;22(4):982-1001. doi: 10.1096/fj.07-9326rev. Epub 2007 Dec 4.'}, {'pmid': '24729696', 'type': 'BACKGROUND', 'citation': 'Schlogl M, Holick MF. Vitamin D and neurocognitive function. 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Epub 2013 Dec 19.'}, {'pmid': '25075535', 'type': 'BACKGROUND', 'citation': 'Wennberg AMV, Gottesman RF, Kaufmann CN, Albert MS, Chen-Edinboro LP, Rebok GW, Kasper JD, Spira AP. Diabetes and cognitive outcomes in a nationally representative sample: the National Health and Aging Trends Study. Int Psychogeriatr. 2014 Oct;26(10):1729-1735. doi: 10.1017/S1041610214001380. Epub 2014 Jul 30.'}, {'pmid': '22340082', 'type': 'BACKGROUND', 'citation': 'Munshi MN, Hayes M, Iwata I, Lee Y, Weinger K. Which aspects of executive dysfunction influence ability to manage diabetes in older adults? Diabet Med. 2012 Sep;29(9):1171-7. doi: 10.1111/j.1464-5491.2012.03606.x.'}, {'pmid': '23804840', 'type': 'BACKGROUND', 'citation': 'Grober E, Hall CB, Hahn SR, Lipton RB. Memory Impairment and Executive Dysfunction are Associated with Inadequately Controlled Diabetes in Older Adults. J Prim Care Community Health. 2011 Oct 1;2(4):229-33. doi: 10.1177/2150131911409945. Epub 2011 Jun 1.'}, {'pmid': '24750335', 'type': 'BACKGROUND', 'citation': 'Retracted: Executive dysfunction in elderly diabetic patients. Geriatr Gerontol Int. 2015 Aug;15(8):1106. doi: 10.1111/ggi.12288. Epub 2014 Apr 21. No abstract available.'}, {'pmid': '25024326', 'type': 'BACKGROUND', 'citation': 'Winkler A, Dlugaj M, Weimar C, Jockel KH, Erbel R, Dragano N, Moebus S. Association of diabetes mellitus and mild cognitive impairment in middle-aged men and women. J Alzheimers Dis. 2014;42(4):1269-77. doi: 10.3233/JAD-140696.'}, {'pmid': '25163604', 'type': 'BACKGROUND', 'citation': 'Geijselaers SLC, Sep SJS, Stehouwer CDA, Biessels GJ. Glucose regulation, cognition, and brain MRI in type 2 diabetes: a systematic review. Lancet Diabetes Endocrinol. 2015 Jan;3(1):75-89. doi: 10.1016/S2213-8587(14)70148-2. Epub 2014 Aug 24.'}, {'pmid': '23948884', 'type': 'BACKGROUND', 'citation': 'Annweiler C, Montero-Odasso M, Llewellyn DJ, Richard-Devantoy S, Duque G, Beauchet O. 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Diabetes Care. 2013 Feb;36(2):260-6. doi: 10.2337/dc12-1204. Epub 2012 Oct 1.'}, {'pmid': '20450340', 'type': 'BACKGROUND', 'citation': 'Penckofer S, Kouba J, Byrn M, Estwing Ferrans C. Vitamin D and depression: where is all the sunshine? Issues Ment Health Nurs. 2010 Jun;31(6):385-93. doi: 10.3109/01612840903437657.'}, {'pmid': '24141790', 'type': 'BACKGROUND', 'citation': 'Drechsler C, Schmiedeke B, Niemann M, Schmiedeke D, Kramer J, Turkin I, Blouin K, Emmert A, Pilz S, Obermayer-Pietsch B, Weidemann F, Breunig F, Wanner C. Potential role of vitamin D deficiency on Fabry cardiomyopathy. J Inherit Metab Dis. 2014 Mar;37(2):289-95. doi: 10.1007/s10545-013-9653-8. Epub 2013 Oct 19.'}, {'pmid': '24923347', 'type': 'BACKGROUND', 'citation': 'Alves MR, Yamamoto T, Arias-Carrion O, Rocha NB, Nardi AE, Machado S, Silva AC. Executive function impairments in patients with depression. 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The incidence of dementia is 1.5 to 2.5 times higher in persons with diabetes than the general population. There is evidence that cognitive decline significantly impacts the ability to self-manage diabetes. Strategies to prevent cognitive decline in persons with diabetes has not been well studied. A recent study reported that in persons who had vitamin D deficiency, the risk for all-cause dementia and Alzheimer's was doubled. Vitamin D receptors are located in the brain and deficiency of vitamin D has been reported to negatively affect the development of brain. Therefore, providing vitamin D supplementation to improve cognitive function is worthy of study. The investigators propose a small, randomized controlled trial to determine the effects of vitamin D3 supplementation in persons with type 2 diabetes who have symptoms of cognitive impairment. Persons will be randomized to receive either weekly vitamin D3 supplementation (50,000 IUs) or a matching comparator (5000 IUs) for a period of three months. The study aims are to determine (1) the effect of vitamin D3 supplementation on cognitive function and (2) the effect of vitamin D3 supplementation on diabetes self-management. A sample of persons with type 2 diabetes (n=62), who have a subjective complaint of a cognitive dysfunction or scoring at least one standard deviation below normal on a cognitive functioning screening test, have vitamin D levels less 30 ng/ml, are not depressed (as this impacts cognitive function), and do not have severe diabetes complication will be recruited. Participants will be phone screened and complete two baseline visits prior to randomization. They will then have phone call and follow-up visits to assess (1) cognitive function using standardized tests to assess for executive function (2) serum measurements (HBA1c, fasting glucose, vitamin D levels, and cardiometabolic profile) and (3) surveys to assess cognitive function as well as self-management behaviors.", 'detailedDescription': "Study Aims Diabetes increases the risk of cognitive dysfunction. The incidence of dementia is 1.5 to 2.5 times higher in persons with diabetes than the general population (1). There is evidence that cognitive decline significantly impacts the ability to self-manage diabetes (2). Strategies to prevent cognitive decline in persons with diabetes has not been well studied. A recent study reported that in persons who had vitamin D deficiency, the risk for all-cause dementia and Alzheimer's was doubled (3). Vitamin D receptors are located in the brain, and deficiency of vitamin D has been reported to negatively affect the development of brain and impact both growth factor signaling and neural activity (4, 5). Therefore, providing vitamin D supplementation to improve cognitive function in persons with diabetes who are at great risk for this comorbid condition is important. The investigators propose a small, randomized controlled trial to determine the effects of vitamin D3 supplementation in persons with type 2 diabetes who have symptoms of cognitive impairment. Persons will be randomized to receive either weekly vitamin D3 supplementation (50,000 IUs) or a matching comparator (5000 IUs) for a period of three months.\n\nPrimary Aim: To determine the effect of vitamin D3 supplementation on cognitive function for persons with type 2 diabetes.\n\nPrimary Hypothesis: Persons receiving weekly vitamin D3 supplementation (50,000 IUs) will have improved cognitive function compared to those receiving the comparator (5000 IUs) at three months.\n\nSecondary Aim: To determine the effect of vitamin D3 supplementation on diabetes self-management.\n\nSecondary Hypothesis: Persons receiving weekly vitamin D3 supplementation (50,000 IUs) will have improved self-management compared to those receiving the comparator (5000 IUs) at three months.\n\nThe importance of this study is several fold. Vitamin D supplementation is a low cost intervention (6), it has minimal side effects (7), and it could have high impact for persons with type 2 diabetes who suffer from cognitive impairment which can significantly affect their diabetes self-management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women and men aged 18 to 75 years\n* Have type 2 diabetes\n* Having a subjective complaint of a cognitive dysfunction or scoring at least one standard deviation below normal on a cognitive functioning screening test\n* Vitamin D level as measured by 25-hydroxyvitamin D (25-OH D) \\< 32 ng/mL\n* Under the care of a healthcare provider\n* Systolic blood pressure ≤160 and diastolic blood pressure ≤100\n\nExclusion Criteria:\n\n* Persons with malabsorption problems (e.g., crohn's disease)\n* Hypercalcemia\n* Supplementation other than a daily multivitamin\n* Severe complications of diabetes (i.e., amputation, blindness, and dialysis)\n* Concomitant use of steroids\n* GFR \\< 60\n* Creatinine \\> 1.2\n* Significant depressive symptoms\n* Having a history of bipolar depression, psychotic disorders, loss of consciousness greater than 5 minutes, or a current alcohol or substance use disorder\n* Other serious medical conditions deemed significant by the PI or medical monitor\n* Concomitant use of cholinesterase inhibitors\n* Concomitant use of anxiolytics, kava kava, St. John's Wort, or Ginkgo Biloba\n* Pregnancy\n* HbA1c \\>13%"}, 'identificationModule': {'nctId': 'NCT02416193', 'acronym': 'THINK-D', 'briefTitle': 'Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D)', 'organization': {'class': 'OTHER', 'fullName': 'Loyola University'}, 'officialTitle': 'Can Vitamin D3 Improve Cognitive Function in Individuals With Type 2 Diabetes? (THINK-D)', 'orgStudyIdInfo': {'id': '206988'}, 'secondaryIdInfos': [{'id': '206988031815', 'type': 'OTHER', 'domain': 'Loyola University Chicago'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Dose', 'description': '50,000 IU cholecalciferol once weekly for three months', 'interventionNames': ['Drug: Cholecalciferol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Dose', 'description': '5,000 IU cholecalciferol once weekly for three months', 'interventionNames': ['Drug: Cholecalciferol']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG', 'otherNames': ['Vitamin D3'], 'description': 'Participants will take randomly assigned high dose cholecalciferol once weekly for three months', 'armGroupLabels': ['High Dose']}, {'name': 'Cholecalciferol', 'type': 'DRUG', 'otherNames': ['Vitamin D3'], 'description': 'Participants will take randomly assigned active comparator cholecalciferol once weekly for three months', 'armGroupLabels': ['Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}], 'overallOfficials': [{'name': 'Mary A Byrn, Ph.D., R.N.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loyola University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loyola University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mary A Byrn', 'investigatorAffiliation': 'Loyola University'}}}}