Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-24 @ 10:41 PM
Study NCT ID:
NCT00736632
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2008-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}], '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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D014807', 'term': 'Vitamin D'}], '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': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cbernal@wustl.edu', 'phone': '314-362-0947', 'title': 'Dr. Carlos Bernal-Mizrachi', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The subjects in the placebo and vitamin D arm were monitored for adverse events from enrollment through completion which was over a course of 4 months.', 'description': 'Adverse events were not collected or assessed from the the non-intervention blood collection arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}], 'classes': [{'title': '0 Month, Office SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.6', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '131.1', 'spread': '14.9', 'groupId': 'OG001'}]}]}, {'title': '0 Month, Office DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.2', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '10.4', 'groupId': 'OG001'}]}]}, {'title': '2 Month, Office SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127.6', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '133.2', 'spread': '14.7', 'groupId': 'OG001'}]}]}, {'title': '2 Month, Office DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.2', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '79.9', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': '4 Month, Office SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '129.6', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '132.7', 'spread': '13.0', 'groupId': 'OG001'}]}]}, {'title': '4 Month, Office DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.6', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '77.9', 'spread': '12.0', 'groupId': 'OG001'}]}]}, {'title': '0 Month, Central MAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103.9', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '107.2', 'spread': '9.9', 'groupId': 'OG001'}]}]}, {'title': '2 Month, Central MAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.6', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '107.8', 'spread': '12.0', 'groupId': 'OG001'}]}]}, {'title': '4 Month, Central MAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102.6', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '105.2', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': '0 Month, Daytime MAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.8', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '101.6', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': '0 Month, Nighttime MAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.4', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '92.2', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': '2 Month, Daytime MAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.6', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '101.7', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': '2 Month, Nighttime MAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.6', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '94.0', 'spread': '13.7', 'groupId': 'OG001'}]}]}, {'title': '4 Month, Daytime MAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '99.1', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': '4 Month, Nighttime MAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.1', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '90.3', 'spread': '11.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2, and 4 months', 'description': '24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Occasional patients had missing blood pressure data or dropped out of the study prior to completion.'}, {'type': 'SECONDARY', 'title': 'Brachial Artery Reactivity Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}], 'classes': [{'title': '0 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': '2 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': '4 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2, and 4 months', 'description': 'Brachial artery response to hyperemia assessed by measuring brachial artery diameter every 30 seconds for 180 seconds after a 5-minute occlusion with arm cuff above systolic blood pressure, with response defined as maximal percentage increase above baseline.', 'unitOfMeasure': 'percentage of dilation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients were unable to obtain adequate ultrasound images for BART analysis or did not show up for some visits'}, {'type': 'SECONDARY', 'title': 'Macrophage Cholesterol Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.072', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 and 4 months', 'description': 'Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.', 'unitOfMeasure': 'unitless (ratio)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was only performed in a subset of patients.'}, {'type': 'SECONDARY', 'title': 'Serum Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}], 'classes': [{'title': '0 Month, serum ca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': '2 Month, serum ca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': '4 Month, serum ca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2, and 4 Month', 'description': 'Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.'}, {'type': 'SECONDARY', 'title': 'HbA1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}], 'classes': [{'title': 'HbA1c 0 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c 2 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c 4 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2, and 4 month', 'description': 'HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.'}, {'type': 'SECONDARY', 'title': 'Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}], 'classes': [{'title': '0 Month, Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.1', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '11.9', 'groupId': 'OG001'}]}]}, {'title': '2 Month, Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.7', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': '4 Month, Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.5', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '42.7', 'spread': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2, and 4 Month', 'description': '25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}], 'classes': [{'title': '0 Month, hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': '2 Month, hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': '4 Month, hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2, and 4 Month', 'description': 'High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Several subjects were unable to give a sample at various time points.'}, {'type': 'SECONDARY', 'title': 'Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}], 'classes': [{'title': '0 Month, Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.7', 'spread': '34.5', 'groupId': 'OG000'}, {'value': '123.3', 'spread': '39.1', 'groupId': 'OG001'}]}]}, {'title': '2 Month, Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137.4', 'spread': '57.6', 'groupId': 'OG000'}, {'value': '124.9', 'spread': '51.0', 'groupId': 'OG001'}]}]}, {'title': '4 Month, Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '138.4', 'spread': '55.2', 'groupId': 'OG000'}, {'value': '128.7', 'spread': '42.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2, and 4 Month', 'description': 'Serum fasting glucose assessed by hexokinase method', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.'}, {'type': 'SECONDARY', 'title': 'Urine Calcium to Creatinine Ratio.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}], 'classes': [{'title': '0 Month, ca to creatinine ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.8', 'spread': '49.8', 'groupId': 'OG000'}, {'value': '88.1', 'spread': '94.8', 'groupId': 'OG001'}]}]}, {'title': '2 Month, ca to creatinine ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102.3', 'spread': '80.1', 'groupId': 'OG000'}, {'value': '114.1', 'spread': '62.5', 'groupId': 'OG001'}]}]}, {'title': '4 Month, ca to creatinine ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.9', 'spread': '80.9', 'groupId': 'OG000'}, {'value': '134.5', 'spread': '106.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 2 and 4 Months', 'description': 'Urine calcium to creatinine ratio assessed by spectrophotometry', 'unitOfMeasure': 'mg/gm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 placebo subject was unable to give samples at the 2 month visit, and 2 subjects were unable to give samples at the 4 month visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'FG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}, {'id': 'FG002', 'title': 'Non-Intervention Blood Collection', 'description': 'Subjects without intervention will give a one-time blood sample for analysis of monocytes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Potential participants will contact the principal investigator or research team through recruitment materials including emails to Washington University/Barnes Jewish/Children's staff, flyers, referrals through other physicians or the recruitment enhancement core, the Veterans Affairs Medical Center and Grace Hill Family Medical Center.", 'preAssignmentDetails': 'The third arm signed consent and are enrolled in the study but only for a single blood draw. They were not randomized and did not receive any intervention. No data was collected for any pre-specified primary or secondary outcomes from these participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.\n\nPlacebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily'}, {'id': 'BG001', 'title': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.\n\nVitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily'}, {'id': 'BG002', 'title': 'Non-intervention Blood Collection', 'description': 'Patients received no intervention. This is a one-time blood collection only.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '13.2', 'groupId': 'BG002'}, {'value': '54.3', 'spread': '1.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '56', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', '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': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-03', 'size': 489132, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-15T11:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2008-08-15', 'resultsFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2008-08-15', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-28', 'studyFirstPostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP)', 'timeFrame': '0, 2, and 4 months', 'description': '24-hour blood pressure collected by ambulatory automated arm cuff, central mean arterial blood pressure (MAP) collected by non-invasive arterial tonometry and pulse wave analysis/pulse wave velocity, office blood pressure collected by manual aneroid sphygmomanometry.'}], 'secondaryOutcomes': [{'measure': 'Brachial Artery Reactivity Testing', 'timeFrame': '0, 2, and 4 months', 'description': 'Brachial artery response to hyperemia assessed by measuring brachial artery diameter every 30 seconds for 180 seconds after a 5-minute occlusion with arm cuff above systolic blood pressure, with response defined as maximal percentage increase above baseline.'}, {'measure': 'Macrophage Cholesterol Metabolism', 'timeFrame': '0 and 4 months', 'description': 'Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.'}, {'measure': 'Serum Calcium', 'timeFrame': '0, 2, and 4 Month', 'description': 'Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA'}, {'measure': 'HbA1C', 'timeFrame': '0, 2, and 4 month', 'description': 'HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood'}, {'measure': 'Vitamin D', 'timeFrame': '0, 2, and 4 Month', 'description': '25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry'}, {'measure': 'hsCRP', 'timeFrame': '0, 2, and 4 Month', 'description': 'High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay'}, {'measure': 'Fasting Glucose', 'timeFrame': '0, 2, and 4 Month', 'description': 'Serum fasting glucose assessed by hexokinase method'}, {'measure': 'Urine Calcium to Creatinine Ratio.', 'timeFrame': '0, 2 and 4 Months', 'description': 'Urine calcium to creatinine ratio assessed by spectrophotometry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin D', 'Insulin Resistance', 'Type 2 Diabetes Mellitus', 'Cardiovascular Disease'], 'conditions': ['Vitamin D Deficiency', 'Insulin Resistance', 'Type 2 Diabetes Mellitus', 'Cardiovascular Disease', 'Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://endo.wustl.edu', 'label': 'Washington University Endocrinology Department website'}]}, 'descriptionModule': {'briefSummary': 'In recent years, vitamin D has been shown not only to be important for bone and calcium metabolism but also for homeostasis of critical tissues involved in vascular disease in patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D deficient hypertensive patients with diabetes', 'detailedDescription': 'This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* 25 (OH) vitamin D levels \\< 25 ng/ml\n* Age 25 to 80 years\n* Not on insulin for diabetes treatment\n* HbA1c 5.5% -9.5%\n* Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP medications\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients with systolic \\>160 or diastolic \\>100 mmHg\n* High urine calcium or history of recurrent kidney stones\n* Cardiovascular disease\n* Stage 3 or worse chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT00736632', 'briefTitle': 'Vitamin D, Insulin Resistance, and Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Vitamin D, Insulin Resistance, and Cardiovascular Disease', 'orgStudyIdInfo': {'id': '201103002'}, 'secondaryIdInfos': [{'id': 'R01HL094818', 'link': 'https://reporter.nih.gov/quickSearch/R01HL094818', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D', 'description': 'Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.', 'interventionNames': ['Drug: Vitamin D3']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DRUG', 'otherNames': ['Vitamin D'], 'description': 'Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily', 'armGroupLabels': ['Vitamin D']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo pill orally daily Calcium carbonate 500 mg twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington Universiy', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Carlos Bernal-MIzrachi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}