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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00459563 |
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Date of registration:
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10/04/2007 |
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Primary sponsor: |
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Public title:
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Vitamin D and Blood Pressure
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Scientific 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 |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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80 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00459563 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Suzanne E Judd, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Name:
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Vin Tangpricha, MD/PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University/VAMC |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: calcitriol
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Drug: Placebo
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Drug: Vitamin D
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Primary Outcome(s)
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25(OH)D
[Time Frame: 3 weeks]
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Blood pressure
[Time Frame: 3 Weeks]
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Secondary Outcome(s)
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Aldosterone
[Time Frame: 3 weeks]
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Angiotensin II
[Time Frame: 3 weeks]
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Parathyroid hormone
[Time Frame: 3 weeks]
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Renin
[Time Frame: 3 weeks]
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Secondary ID(s)
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648-2006
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VAMC Atlanta R&D AREF 283001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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