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Hypothesis: Vitamin D supplementation lower renin-angiotensin system activity in obesity.
Specific Aim: To investigate whether Vitamin D supplementation in obesity improves the vascular sensitivity to angiotensin II.
Vitamin D deficiency and obesity are international epidemics that have both been associated with increased activity of the renin-angiotensin system (RAS). Because increased RAS activity is associated with cardiovascular disease, interventions to lower RAS will have favorable public health impacts.
This study aims to evaluate whether the supplementation of Vitamin D in obese subjects will lower local tissue RAS activity. RAS activity will be evaluated by cross-sectional measurement of RAS components and by quantifying the vascular response to an infusion of angiotensin II. Subjects will be studied while Vitamin D deficient, and will return for repeat study following Vitamin D supplementation, for comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental | 15000IU of vitamin D3 daily: open-label, single-arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (cholecalciferol) | Dietary Supplement | cholecalciferol 15,000 IU daily for 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II | baseline and 1 month following vitamin D3 therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II | baseline and 1 month following vitamin D3 therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan S Williams, MD, MMSc | Brigham and Women's Hospital | Principal Investigator |
| Anand Vaidya, MD | Brigham and Women's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 | This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3 | This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II | Posted | Mean | Standard Deviation | mmHg | baseline and 1 month following vitamin D3 therapy |
|
|
2.5 years
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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 | Vitamin D3 | This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks. |
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This was a small physiologic study intended to provide insights on the influence of vitamin D3 on the renin-angiotensin system and vascular function. It is not generalizable to clinical practice. This is not a standard "clinical trial".
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan S. Williams | Brigham and Women's Hospital, Harvard Medical School | 6177325666 | jwilliams5@partners.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D014808 | Vitamin D Deficiency |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pre-Intervention Mean Arterial Pressure | Mean | Standard Deviation | mmHg |
|
| Pre-Intervention 25-hydroxyvitamin D3 | Mean | Standard Deviation | ng/mL |
|
| Pre-Intervention Parathyroid hormone concentration | Mean | Standard Deviation | pg/mL |
|
| Pre-Intervention Serum calcium concentration | Mean | Standard Deviation | mg/dL |
|
|
|
| Secondary | The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II | Posted | Mean | Standard Deviation | mL/min/1.72m2 | baseline and 1 month following vitamin D3 therapy |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |