Vitamin D, Insulin Resistance, and Cardiovascular Disease
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|ClinicalTrials.gov Identifier: NCT00736632|
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Insulin Resistance Type 2 Diabetes Mellitus Cardiovascular Disease Hypertension||Drug: Vitamin D3 Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vitamin D, Insulin Resistance, and Cardiovascular Disease|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||January 13, 2019|
|Actual Study Completion Date :||January 13, 2019|
Placebo Comparator: Placebo
Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily.
Placebo pill orally daily Calcium carbonate 500 mg twice daily
Active Comparator: Vitamin D
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Drug: Vitamin D3
Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
Other Name: Vitamin D
- Hypertension (24h Blood Pressure, Central Blood Pressure, and Office BP) [ Time Frame: 0, 2, and 4 months ]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.
- Brachial Artery Reactivity Testing [ Time Frame: 0, 2, and 4 months ]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.
- Macrophage Cholesterol Metabolism [ Time Frame: 0 and 4 months ]Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake.
- Serum Calcium [ Time Frame: 0, 2, and 4 Month ]Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA
- HbA1C [ Time Frame: 0, 2, and 4 month ]HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood
- Vitamin D [ Time Frame: 0, 2, and 4 Month ]25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry
- hsCRP [ Time Frame: 0, 2, and 4 Month ]High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay
- Fasting Glucose [ Time Frame: 0, 2, and 4 Month ]Serum fasting glucose assessed by hexokinase method
- Urine Calcium to Creatinine Ratio. [ Time Frame: 0, 2 and 4 Months ]Urine calcium to creatinine ratio assessed by spectrophotometry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736632
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Carlos Bernal-MIzrachi, M.D.||Washington University School of Medicine|