Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-04-30

Brief Summary

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High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is more common during months where UVB radiation from the sun is absent, and vitamin D has been associated with high blood pressure. This study will evaluate the effect of vitamin D replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.

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Detailed Description

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Conditions

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Hypertension Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cholecalciferol

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

3 tablets of 1000 IU daily for 20 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3 placebo tablets daily for 20 weeks

Interventions

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Cholecalciferol

3 tablets of 1000 IU daily for 20 weeks

Intervention Type DRUG

Placebo

3 placebo tablets daily for 20 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Well-regulated arterial hypertension
* Office blood pressure \> 120/70 mmHg

Exclusion Criteria

* Pregnancy or nursing
* Cancer
* Alcohol abuse
* Continuous glucocorticoid or NSAID treatment
* 24-hour blood pressure \> 150/95 mmHg
* Hypercalcemia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No