Vitamin D and Blood Pressure

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2011

Interventions

  • Drug: Vitamin D
    • 200,000 IU once weekly for 3 weeks (600,000 IU total dose)
  • Drug: calcitriol
    • calcitriol 0.5 mcg twice a day for 1 week
  • Drug: Placebo
    • Placebo once a week for 3 weeks

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Active Comparator: Cholecalciferol
    • Cholecalciferol
  • Active Comparator: Calcitriol
    • Calcitriol

Clinical Trial Outcome Measures

Primary Measures

  • Blood pressure
    • Time Frame: 3 Weeks
  • 25(OH)D
    • Time Frame: 3 weeks

Secondary Measures

  • Parathyroid hormone
    • Time Frame: 3 weeks
  • Renin
    • Time Frame: 3 weeks
  • Aldosterone
    • Time Frame: 3 weeks
  • Angiotensin II
    • Time Frame: 3 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Atlanta VA Medical Center
  • Collaborator
    • Emory University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vin Tangpricha, Staff Physician – Atlanta VA Medical Center
  • Overall Official(s)
    • Vin Tangpricha, MD/PhD, Principal Investigator, Emory University/VAMC
    • Suzanne E Judd, MPH, Study Director, Emory University

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