Vitamin D and Blood Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once a week for 3 weeks

Cholecalciferol

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

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

Calcitriol

Group Type ACTIVE_COMPARATOR

calcitriol

Intervention Type DRUG

calcitriol 0.5 mcg twice a day for 1 week

Interventions

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Vitamin D

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

Intervention Type DRUG

calcitriol

calcitriol 0.5 mcg twice a day for 1 week

Intervention Type DRUG

Placebo

Placebo once a week for 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes