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

June 18, 2012 updated by: Erling Bjerregaard Pedersen, Regional Hospital Holstebro

Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holstebro, Denmark, 7500
        • Department of medical research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
3 placebo tablets daily for 20 weeks
Active Comparator: Cholecalciferol
Drug: Cholecalciferol
3 tablets of 1000 IU daily for 20 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-hour systolic blood pressure
Time Frame: 20 weeks
20 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma renin concentration
Time Frame: 20 weeks
20 weeks
Plasma concentration of angiotensin II
Time Frame: 20 weeks
20 weeks
Plasma concentration of aldosterone
Time Frame: 20 weeks
20 weeks
Plasma concentration of c-reactive protein
Time Frame: 20 weeks
20 weeks
Urine albumin creatinine ratio
Time Frame: 20 weeks
20 weeks
Urine calcium creatinine ratio
Time Frame: 20 weeks
20 weeks
Plasma concentration of 25-hydroxycholecalciferol
Time Frame: 5 weeks
5 weeks
Serum concentration of FGF-23
Time Frame: 20 weeks
20 weeks
Augmentation index and central blood pressure
Time Frame: 20 weeks
20 weeks
Pulse wave velocity
Time Frame: 20 weeks
20 weeks
Heart rate variability
Time Frame: 20 weeks
20 weeks
Plasma concentration of ionized calcium
Time Frame: 5 weeks
5 weeks
Plasma concentration of phosphate
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Holstebro

Investigators

  • Principal Investigator: Thomas Larsen, M.D., Departments of Medical Research, Holstebro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

July 19, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBP-TL-2010-2
  • M-20100120 (Other Identifier: The Regional Committee on Biomedical Research Ethics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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