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Vitamin D and Blood Pressure

This study has been terminated.
(Inadequate enrollment)
Sponsor:
Collaborator:
Emory University
Information provided by:
Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT00459563
First received: April 10, 2007
Last updated: August 2, 2011
Last verified: April 2009
History of Changes
  Purpose

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 Intervention
Hypertension
 Drug: Vitamin D
Drug: calcitriol
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Atlanta VA Medical Center:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
  • 25(OH)D [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Parathyroid hormone [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Renin [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Aldosterone [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Angiotensin II [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo once a week for 3 weeks
Active Comparator: Cholecalciferol
Cholecalciferol
 Drug: Vitamin D
200,000 IU once weekly for 3 weeks (600,000 IU total dose)
Active Comparator: Calcitriol
Calcitriol
 Drug: calcitriol
calcitriol 0.5 mcg twice a day for 1 week

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459563

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

No publications provided

Responsible Party: Vin Tangpricha, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00459563     History of Changes
Other Study ID Numbers: 648-2006, VAMC Atlanta R&D AREF 283001
Study First Received: April 10, 2007
Last Updated: August 2, 2011
Health Authority: United States: Federal Government

Keywords provided by Atlanta VA Medical Center:
vitamin D
blood pressure
hypertension
Vitamin D insufficient
Systolic blood pressure between 130 and 150 mmHg

Additional relevant MeSH terms:
Hypertension
Vitamin D Deficiency
Vascular Diseases
Cardiovascular Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcitriol
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013