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

Primary Purpose

Hypertension, Vitamin D Deficiency

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, blood pressure, vitamin d, winter, cholecalciferol, arterial stiffness, renin, angiotensin, aldosterone, calcium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cholecalciferol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

24-hour systolic blood pressure

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2010
Last Updated
June 18, 2012
Sponsor
Regional Hospital Holstebro
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1. Study Identification

Unique Protocol Identification Number
NCT01166165
Brief Title
Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension
Official Title
Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vitamin D Deficiency
Keywords
Hypertension, blood pressure, vitamin d, winter, cholecalciferol, arterial stiffness, renin, angiotensin, aldosterone, calcium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
3 tablets of 1000 IU daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 placebo tablets daily for 20 weeks
Primary Outcome Measure Information:
Title
24-hour systolic blood pressure
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Plasma renin concentration
Time Frame
20 weeks
Title
Plasma concentration of angiotensin II
Time Frame
20 weeks
Title
Plasma concentration of aldosterone
Time Frame
20 weeks
Title
Plasma concentration of c-reactive protein
Time Frame
20 weeks
Title
Urine albumin creatinine ratio
Time Frame
20 weeks
Title
Urine calcium creatinine ratio
Time Frame
20 weeks
Title
Plasma concentration of 25-hydroxycholecalciferol
Time Frame
5 weeks
Title
Serum concentration of FGF-23
Time Frame
20 weeks
Title
Augmentation index and central blood pressure
Time Frame
20 weeks
Title
Pulse wave velocity
Time Frame
20 weeks
Title
Heart rate variability
Time Frame
20 weeks
Title
Plasma concentration of ionized calcium
Time Frame
5 weeks
Title
Plasma concentration of phosphate
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Larsen, M.D.
Organizational Affiliation
Departments of Medical Research, Holstebro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Research
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22854639
Citation
Larsen T, Mose FH, Bech JN, Hansen AB, Pedersen EB. Effect of cholecalciferol supplementation during winter months in patients with hypertension: a randomized, placebo-controlled trial. Am J Hypertens. 2012 Nov;25(11):1215-22. doi: 10.1038/ajh.2012.111. Epub 2012 Aug 2.
Results Reference
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Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension

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