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Vitamin D and Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459563
Recruitment Status : Withdrawn (Inadequate enrollment)
First Posted : April 12, 2007
Last Update Posted : January 8, 2014
Emory University
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Vitamin D Drug: calcitriol Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo once a week for 3 weeks

Active Comparator: Cholecalciferol
Drug: Vitamin D
200,000 IU once weekly for 3 weeks (600,000 IU total dose)

Active Comparator: Calcitriol
Drug: calcitriol
calcitriol 0.5 mcg twice a day for 1 week

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 3 Weeks ]
  2. 25(OH)D [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Parathyroid hormone [ Time Frame: 3 weeks ]
  2. Renin [ Time Frame: 3 weeks ]
  3. Aldosterone [ Time Frame: 3 weeks ]
  4. Angiotensin II [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459563

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United States, Georgia
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Atlanta VA Medical Center
Emory University
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Principal Investigator: Vin Tangpricha, MD/PhD Emory University/VAMC
Study Director: Suzanne E Judd, MPH Emory University

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Responsible Party: Vin Tangpricha, Staff Physician, Atlanta VA Medical Center Identifier: NCT00459563     History of Changes
Other Study ID Numbers: 648-2006
VAMC Atlanta R&D AREF 283001
First Posted: April 12, 2007    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014
Keywords provided by Vin Tangpricha, Atlanta VA Medical Center:
vitamin D
blood pressure
Vitamin D insufficient
Systolic blood pressure between 130 and 150 mmHg
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents