Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL094818 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| American Diabetes Association | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily. |
|
| Vitamin D | Active Comparator | Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos Bernal-MIzrachi, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Universiy | St Louis | Missouri | 63110 | United States |
Not provided
| Label | URL |
|---|---|
| Washington University Endocrinology Department website | View source |
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily. Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily |
| FG001 | Vitamin D | Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily. Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily |
| FG002 | Non-Intervention Blood Collection | Subjects without intervention will give a one-time blood sample for analysis of monocytes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily. Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily |
| BG001 | Vitamin D |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Occasional patients had missing blood pressure data or dropped out of the study prior to completion. | Posted | Mean | Standard Deviation | mm Hg | 0, 2, and 4 months |
|
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.
Adverse events were not collected or assessed from the the non-intervention blood collection arm.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients in the control group will receive placebo pills (instead of vitamin D) and calcium carbonate 500 mg twice daily. Placebo: Placebo pill orally daily Calcium carbonate 500 mg twice daily |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Bernal-Mizrachi | Washington University in St. Louis | 314-362-0947 | cbernal@wustl.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2019 | Nov 15, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D007333 | Insulin Resistance |
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo pill orally daily Calcium carbonate 500 mg twice daily |
|
| 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 |
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.
Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
| BG002 | Non-intervention Blood Collection | Patients received no intervention. This is a one-time blood collection only. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily. Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily |
|
|
| 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. | Some patients were unable to obtain adequate ultrasound images for BART analysis or did not show up for some visits | Posted | Mean | Standard Deviation | percentage of dilation | 0, 2, and 4 months |
|
|
|
| Secondary | Macrophage Cholesterol Metabolism | Macrophage uptake of labeled oxidized low density lipoprotein, assessed by the ratio of post-treatment cholesterol uptake to baseline uptake. | This analysis was only performed in a subset of patients. | Posted | Mean | Standard Deviation | unitless (ratio) | 0 and 4 months |
|
|
|
| Secondary | Serum Calcium | Serum calcium assessed by photometric assessment after calcium reaction with NM-BAPTA, then with EDTA | 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. | Posted | Mean | Standard Deviation | mg/dL | 0, 2, and 4 Month |
|
|
|
| Secondary | HbA1C | HbA1c percentage assessed by turbidimetric inhibition immunoassay for hemolyzed whole blood | 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. | Posted | Mean | Standard Deviation | percentage | 0, 2, and 4 month |
|
|
|
| Secondary | Vitamin D | 25(OH) Vitamin D assess by liquid chromatography with tandem mass spectrometry | Posted | Mean | Standard Deviation | pg/mL | 0, 2, and 4 Month |
|
|
|
| Secondary | hsCRP | High sensitivity C-reactive protein assessed by particle-enhanced immunoturbidimetric assay | Several subjects were unable to give a sample at various time points. | Posted | Mean | Standard Deviation | mg/L | 0, 2, and 4 Month |
|
|
|
| Secondary | Fasting Glucose | Serum fasting glucose assessed by hexokinase method | 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. | Posted | Mean | Standard Deviation | mg/dL | 0, 2, and 4 Month |
|
|
|
| Secondary | Urine Calcium to Creatinine Ratio. | Urine calcium to creatinine ratio assessed by spectrophotometry | 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. | Posted | Mean | Standard Deviation | mg/gm | 0, 2 and 4 Months |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Vitamin D | Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily. Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| 2 Month |
|
|
| 4 Month |
|
|
| 2 Month, serum ca |
|
|
| 4 Month, serum ca |
|
|
| HbA1c 2 month |
|
|
| HbA1c 4 month |
|
|
| 2 Month, Vitamin D |
|
|
| 4 Month, Vitamin D |
|
|
| 2 Month, hsCRP |
|
|
| 4 Month, hsCRP |
|
|
| 2 Month, Fasting Glucose |
|
|
| 4 Month, Fasting Glucose |
|
|
| 2 Month, ca to creatinine ratio |
|
|
| 4 Month, ca to creatinine ratio |
|
|