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| ID | Type | Description | Link |
|---|---|---|---|
| U54RR022762 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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Vitamin D is a natural nutrient. A little comes from our normal daily diet. Most of it comes from our skin after we have been in sunlight. If we have darker skin, we make less vitamin D. Vitamin D balances the calcium in our body. If our vitamin D levels get too low, it can cause health problems. It may increase our chance of getting high blood pressure or diabetes. Another problem we may have if our vitamin D levels are low is that our blood vessels may not work normally. These are important health problems for anyone. Because African Americans have darker skin, they are more likely than most other racial/ethnic groups to have low vitamin D levels. This study will look at treating African Americans with low vitamin D levels.
The goal of this study is to see how vitamin D helps blood vessels work. The investigators will do this study in African Americans who are overweight, have high blood pressure and have low vitamin D levels. The investigators will see if getting the vitamin D level to a normal value will improve how blood vessels work. The dose of vitamin D that will be given in this study is a high dose that is given to people with low vitamin D levels.
Cardiovascular Disease (CVD) and related disorders remain the leading cause of death in the nation. Hypovitaminosis D has been linked not only to several cardiovascular (CV) risk factors including hypertension, diabetes, obesity but also to increased rates of CVD. Thus,hypovitaminosis D presents a common pathway for a select subgroup with a clustering of CV risk factors in a profile that is predominant among ethnic minorities. Indeed, hypovitaminosis D is highly prevalent with an estimated 55% of the US adult population having levels at or below 30 ng/ml, and over 80% of African Americans having suboptimal values. Thus, we propose a twelve week randomized double-blind, placebo controlled pilot trial to assess the effect on vascular function and CV risk factors of 100,000 IU Vitamin D3 given every 4 weeks to overweight, hypertensive African-Americans with hypovitaminosis D. To our knowledge, the proposed project is the first to assess the effect of 'high-dose' Vitamin D3 administration on vascular function.We believe this study is also the first to examine the impact at a molecular level of Vitamin D3 repletion on the key mediators of cardio-metabolic pathways in humans. If our study results support our working hypothesis, we will be positioned to propose a larger scale study to detect a therapeutic effect on more definitive, clinical cardiovascular endpoints across a more diverse population.
Objectives:
1. Assess the role of Vitamin D3 treatment on vascular function in high risk subjects.
Primary Outcome: The primary outcome variable is pulse wave velocity (PWV, unit - m/s) for vascular stiffness assessed by radial artery tonometry (via SphygmoCor). The hypothesis for the primary analysis is that a greater increase in the PWV will occur in the Vitamin D3 treatment group than in the placebo group.
Secondary Outcome: Vascular/endothelial function as determined by measuring non-invasive vascular finger plethysmography (via EndoPat). Additional surrogates to be assessed as secondary markers of vascular/endothelial function include sitting and 24 hour ambulatory blood pressure measurements and spot urine protein/creatinine ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Vitamin D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Wave Velocity for Vascular Stiffness | The primary outcome variable is pulse wave velocity (PWV) for vascular stiffness. The hypothesis is that a greater decrease in the PWV will occur with the Vitamin D3 treatment. PWV is the speed at which the arterial pulse wave travels through the arteries in the cardiovascular system. It is considered the gold standard for the assessment of arterial elastance (stiffness) and determined by radial artery applanation tonometry using the SphygmoCor device. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Sitting and 24 Ambulatory Blood Pressure | Improved vascular function as determined by measuring sitting and 24 Hour Ambulatory Blood Pressure. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Martins, MD | Charles Drew University of Medicine and Science | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3 will be given every 4 weeks. |
| FG001 | Vitamin D | Two 50,000 IU tablets of oral Vitamin D3 given every 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks. |
| BG001 | Vitamin D | Vitamin D: Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Pulse Wave Velocity for Vascular Stiffness | The primary outcome variable is pulse wave velocity (PWV) for vascular stiffness. The hypothesis is that a greater decrease in the PWV will occur with the Vitamin D3 treatment. PWV is the speed at which the arterial pulse wave travels through the arteries in the cardiovascular system. It is considered the gold standard for the assessment of arterial elastance (stiffness) and determined by radial artery applanation tonometry using the SphygmoCor device. | Posted | Mean | Standard Deviation | m/s | 12 Weeks |
|
12 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Two tablets of oral placebo (microcrystalline cellulose), matching in appearance to the Vitamin D3, will be given every 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin = 9.6 G/DL | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Martins | Charles Drew University of Medicine and Science | 323-568-3353 | davidmartins@cdrewu.edu |
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo |
| Drug |
Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index, Categorical | Count of Participants | Participants |
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| Waist Circumference Groups | Count of Participants | Participants |
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| Blood Pressure (Systolic) | Mean | Standard Deviation | mmHg |
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| Blood Pressure (Diastolic) | Mean | Standard Deviation | mmHg |
|
| Augmentation Index | Augmentation Index (Aix) is the percentage of central pulse pressure (central systolic minus diastolic pressure) attributable to the reflection of the pulse wave at arterial bifurcation points and interface of the large arteries and small resistance arteries. It is the index of aortic pressure wave reflection, defined as the ratio of augmented ascending aortic pressure (generated backward traveling pressure waves) to the central pulse pressure at the aortic root: where (Ps - Pi) / (Ps - Pd) Ps = peak systolic pressure, Pi = pressure at reflection point, and Pd = minimum diastolic pressure. | Mean | Standard Deviation | percentage of central pulse pressure |
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| Urine Isoprostane | Mean | Standard Deviation | ng/mg |
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| Serum 25(OH)D Level | Mean | Standard Deviation | nmol/L |
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| Serum Calcium Level | Mean | Standard Deviation | mg/dl |
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| Intact Parathyroid Hormone (PTH) Level | Mean | Standard Deviation | pmol/L |
|
Vitamin D: Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
|
|
| Secondary | Changes in Sitting and 24 Ambulatory Blood Pressure | Improved vascular function as determined by measuring sitting and 24 Hour Ambulatory Blood Pressure. | Posted | Mean | Standard Deviation | mmHg | 12 weeks |
|
|
|
| 0 |
| 65 |
| 4 |
| 65 |
| 12 |
| 65 |
| EG001 | Vitamin D | Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks. | 0 | 65 | 4 | 65 | 14 | 65 |
| Post Biopsy Bleeding at Wound Site | Surgical and medical procedures | Systematic Assessment |
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| Pituitary Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Elevated Blood Pressure | Vascular disorders | Systematic Assessment |
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| Allergic Reaction | Immune system disorders | Systematic Assessment |
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| Atypical Chest Pain | Cardiac disorders | Systematic Assessment |
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| Syncope | General disorders | Systematic Assessment |
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| High Platelet Count = 493 Thousand/UL | Blood and lymphatic system disorders | Systematic Assessment |
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| Hematocrit = 30.2% | Blood and lymphatic system disorders | Systematic Assessment |
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| Elevated WBC = 14.9 | Blood and lymphatic system disorders | Systematic Assessment |
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| Low White Blood Cell Count = 2.9 | Blood and lymphatic system disorders | Systematic Assessment |
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| Peripheral Edema, Left and Right Feet | Blood and lymphatic system disorders | Systematic Assessment |
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| Low Platelet Count = 107 | Blood and lymphatic system disorders | Systematic Assessment |
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| Elevated Platelet = 456 | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Elevated iPTH = 213 | Endocrine disorders | Systematic Assessment |
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| Elevated iPTH = 236 | Endocrine disorders | Systematic Assessment |
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| Elevated SGOT = 103 | Gastrointestinal disorders | Systematic Assessment |
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| Elevated SGPT = 106 | Gastrointestinal disorders | Systematic Assessment |
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| Gallbladder Removed | Hepatobiliary disorders | Systematic Assessment |
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| Infection at Biopsy Site | Infections and infestations | Systematic Assessment |
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| Phosphate = 5.0 MG/DL | Metabolism and nutrition disorders | Systematic Assessment |
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| iPTH = 7 PG/ML | Metabolism and nutrition disorders | Systematic Assessment |
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| Back Discomfort from Car Accident | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Right Hip Pain; Osteoarthritis Flare Up; Exacerbation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pituitary Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Creatinine = 1.44 MG/DL | Renal and urinary disorders | Systematic Assessment |
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| Creatinine Random Urine = 461.3 | Renal and urinary disorders | Systematic Assessment |
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| Skin Sensitivity to Adhesive Tape Post Biopsy | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Elevated Blood Pressure | Vascular disorders | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| 24 Hour Blood Pressure (Systolic) |
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| 24 Hour Blood Pressure (Diastolic) |
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