- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00459563
Vitamin D and Blood Pressure
January 7, 2014 updated by: Vin Tangpricha, Atlanta VA Medical Center
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30033
- VAMC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo once a week for 3 weeks
|
Active Comparator: Cholecalciferol
|
200,000 IU once weekly for 3 weeks (600,000 IU total dose)
|
Active Comparator: Calcitriol
|
calcitriol 0.5 mcg twice a day for 1 week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: 3 Weeks
|
3 Weeks
|
25(OH)D
Time Frame: 3 weeks
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parathyroid hormone
Time Frame: 3 weeks
|
3 weeks
|
Renin
Time Frame: 3 weeks
|
3 weeks
|
Aldosterone
Time Frame: 3 weeks
|
3 weeks
|
Angiotensin II
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vin Tangpricha, MD/PhD, Emory University/VAMC
- Study Director: Suzanne E Judd, MPH, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 10, 2007
First Submitted That Met QC Criteria
April 11, 2007
First Posted (Estimate)
April 12, 2007
Study Record Updates
Last Update Posted (Estimate)
January 8, 2014
Last Update Submitted That Met QC Criteria
January 7, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Vitamin D
- Calcitriol
Other Study ID Numbers
- 648-2006
- VAMC Atlanta R&D AREF 283001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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