Vitamin D and Blood Pressure

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00459563

Enrollment

Registered

2007-04-12

Start date

2007-03-31

Completion date

2011-12-31

Last updated

2014-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

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

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Blood pressure	3 Weeks
25(OH)D	3 weeks

Secondary

Measure	Time frame
Aldosterone	3 weeks
Angiotensin II	3 weeks
Parathyroid hormone	3 weeks
Renin	3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026