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WithdrawnNCT00459563Updated Jan 8, 2014

Vitamin D and Blood Pressure

An interventional study of Vitamin D and calcitriol in Hypertension, sponsored by Atlanta VA Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-08.

Sponsored by Atlanta VA Medical Center · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Inadequate enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • vitamin D
  • blood pressure
  • hypertension
  • Vitamin D insufficient
  • Systolic blood pressure between 130 and 150 mmHg
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Atlanta VA Medical Center is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Active comparator
    Cholecalciferol

    Cholecalciferol

    Drug: Vitamin D

  • Active comparator
    Calcitriol

    Calcitriol

    Drug: calcitriol

Interventions

  • DrugVitamin D

    200,000 IU once weekly for 3 weeks (600,000 IU total dose)

  • Drugcalcitriol

    calcitriol 0.5 mcg twice a day for 1 week

  • DrugPlacebo

    Placebo once a week for 3 weeks

06

What researchers measure

Primary outcomes

  1. Blood pressure

    Time frame: 3 Weeks

  2. 25(OH)D

    Time frame: 3 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • VAMC
    Decatur, Georgia 30033, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00459563
Lead sponsor
Atlanta VA Medical Center
Collaborators
Emory University
Responsible party
Vin Tangpricha (Staff Physician, Atlanta VA Medical Center) — Principal investigator
First posted
Apr 12, 2007
Start date
Mar 2007
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jan 8, 2014

Study contacts

Vin Tangpricha, MD/PhD
principal investigator · Emory University/VAMC
Suzanne E Judd, MPH
study director · Emory University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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