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Clinical Trial Details

Trial ID: L5974
Source ID: NCT00736632
Associated Drug: Vitamin D3
Title: Vitamin D, Insulin Resistance, and Cardiovascular Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00736632/results
Conditions: Vitamin D Deficiency|Insulin Resistance|Type 2 Diabetes Mellitus|Cardiovascular Disease|Hypertension
Interventions: DRUG: Vitamin D3|DRUG: Placebo
Outcome Measures: Primary: Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP), 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., 0, 2, and 4 months | Secondary: Brachial Artery Reactivity Testing, 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., 0, 2, and 4 months|Macrophage Cholesterol Metabolism, Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake., 0 and 4 months|Serum Calcium, Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA, 0, 2, and 4 Month|HbA1C, HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood, 0, 2, and 4 month|Vitamin D, 25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry, 0, 2, and 4 Month|hsCRP, High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay, 0, 2, and 4 Month|Fasting Glucose, Serum fasting glucose assessed by hexokinase method, 0, 2, and 4 Month|Urine Calcium to Creatinine Ratio., Urine calcium to creatinine ratio assessed by spectrophotometry, 0, 2 and 4 Months
Sponsor/Collaborators: Sponsor: Washington University School of Medicine | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)|American Diabetes Association
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 125
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2006-05
Completion Date: 2019-01-13
Results First Posted: 2020-02-10
Last Update Posted: 2020-02-10
Locations: Washington Universiy, Saint Louis, Missouri, 63110, United States
URL: https://clinicaltrials.gov/show/NCT00736632