Vitamin D and Blood Pressure

Study Overview
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Brief Summary
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Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after exposure to sunlight and is essential for maintaining normal calcium balance. One past study has suggested that vitamin D may be helpful for blood pressure. This study will test whether pills containing cholecalciferol (a form of vitamin D) or calcitriol (the active form of vitamin D) can treat high blood pressure. The investigators plan to enroll up to 80 subjects at the Atlanta VA Medical Center. Participation in the study is expected to last up to 4 weeks. Subjects will be assigned to cholecalciferol, calcitriol or placebo). A 24-hour blood pressure monitor will be worn at the beginning and end of the study to determine blood pressure changes. Renin, PTH, angiotensin-II, and aldosterone levels will also be measured at the beginning and end of the study.

Official Title
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A Randomized Placebo-controlled Double Blinded Trial to Evaluate Cholecalciferol (Vitamin D3) and Calcitriol Treatment on Reducing Blood Pressure in Middle Aged Adults With Stage I Hypertension and Vitamin D Deficiency

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Vitamin D
* Drug: calcitriol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be over the age of 18 Vitamin D levels between 10 and 30 ng/ml Systolic blood pressure between 130 and 150 mmHg Exclusion Criteria: Current use of anti-hypertensive medication Inability to understand the consent form Inability to return ABP monitor within 24-48 hours after visit Alcohol dependence Diagnosis of chronic kidney disease History of heart disease History of stroke Inability to comply with study protocol Current treatment for cancer Narcotic dependence Current use of greater than 2000 IU of vitamin D Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo once a week for 3 weeks<br>|
| Active Comparator: Cholecalciferol<br>Cholecalciferol | Drug: Vitamin D<br>* 200,000 IU once weekly for 3 weeks (600,000 IU total dose)<br>|
| Active Comparator: Calcitriol<br>Calcitriol | Drug: calcitriol<br>* calcitriol 0.5 mcg twice a day for 1 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 3 Weeks | 
| 25(OH)D |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parathyroid hormone |  | 3 weeks | 
| Renin |  | 3 weeks | 
| Aldosterone |  | 3 weeks | 
| Angiotensin II |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, blood pressure, hypertension, Vitamin D insufficient, Systolic blood pressure between 130 and 150 mmHg