NCT00459563

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

Enrollment Period

4.8 years

First QC Date

April 10, 2007

Last Update Submit

January 7, 2014

Conditions

Hypertension

Keywords

vitamin Dblood pressurehypertensionVitamin D insufficientSystolic blood pressure between 130 and 150 mmHg

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    3 Weeks

  • 25(OH)D

    3 weeks

Secondary Outcomes (4)

  • Parathyroid hormone

    3 weeks

  • Renin

    3 weeks

  • Aldosterone

    3 weeks

  • Angiotensin II

    3 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Cholecalciferol

ACTIVE COMPARATOR

Cholecalciferol

Drug: Vitamin D

Calcitriol

ACTIVE COMPARATOR

Calcitriol

Drug: calcitriol

Interventions

Vitamin DDRUG

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

Cholecalciferol
calcitriolDRUG

calcitriol 0.5 mcg twice a day for 1 week

Calcitriol
PlaceboDRUG

Placebo once a week for 3 weeks

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VAMC

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Vitamin DCalcitriol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsDihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Vin Tangpricha, MD/PhD

    Emory University/VAMC

    PRINCIPAL INVESTIGATOR

  • Suzanne E Judd, MPH

    Emory University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 12, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

US(1)