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Styrian Vitamin D Hypertension Trial

Primary Purpose

Arterial Hypertension, Vitamin D Deficiency

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • 25-hydroxyvitamin D levels below 30 ng/ml (75 nmol/L)
  • Arterial hypertension defined according to recent guidelines as an average office blood pressure on at least two occasions of systolic ≥ 140 and/or diastolic ≥ 90 mmHg or a mean 24-hour ABP of systolic ≥ 125 and/or diastolic ≥ 80, or a home blood pressure of systolic ≥ 130 and/or diastolic ≥ 85 or ongoing antihypertensive treatment which was initiated due to arterial hypertension
  • Age of ≥ 18 years
  • Written informed consent.

Exclusion Criteria:

  • Hypercalcemia defined a serum calcium >2.65 mmol/L
  • Pregnancy or lactating women
  • Drug intake as part of another clinical study
  • Acute coronary syndrome or cerebrovascular events in the previous 2 weeks
  • Glomerular filtration rate (GFR) according to the MDRD formula < 15 ml/min/1.73m²
  • Systolic 24-hour ABP > 160 mm Hg or < 120 mm Hg
  • Diastolic 24-hour ABP > 100 mm Hg
  • Change of antihypertensive treatment (drugs and/or lifestyle) in the previous 4 weeks or planned changes of antihypertensive treatment during the study
  • Any disease with an estimated life expectancy below 1 year
  • Any clinically significant acute disease requiring drug treatment
  • Chemotherapy or radiation therapy during the study
  • Regular intake of more than 880 International Units (IU) vitamin D per day in the last four weeks before study entry or during the study

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D3

Placebo

Arm Description

The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3; producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks

Oily drops as placebo

Outcomes

Primary Outcome Measures

24-hour systolic ambulatory blood pressure

Secondary Outcome Measures

24-hour diastolic ambulatory blood pressure
N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)
corrected QT interval (Bazett formula)
Renin
Plasma renin concentration
Aldosterone
Plasma aldosterone concentration
24-hour urinary albumin excretion
HOMA-IR
HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance)
Triglycerides
HDL-cholesterol
Pulse wave velocity

Full Information

First Posted
May 9, 2014
Last Updated
November 23, 2014
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT02136771
Brief Title
Styrian Vitamin D Hypertension Trial
Official Title
Styrian Vitamin D Hypertension Trial: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Systolic Ambulatory Blood Pressure in Vitamin D Deficient Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3 supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity, N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Active Comparator
Arm Description
The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3; producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oily drops as placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3, producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
24-hour systolic ambulatory blood pressure
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
24-hour diastolic ambulatory blood pressure
Time Frame
8 weeks
Title
N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)
Time Frame
8 weeks
Title
corrected QT interval (Bazett formula)
Time Frame
8 weeks
Title
Renin
Description
Plasma renin concentration
Time Frame
8 weeks
Title
Aldosterone
Description
Plasma aldosterone concentration
Time Frame
8 weeks
Title
24-hour urinary albumin excretion
Time Frame
8 weeks
Title
HOMA-IR
Description
HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance)
Time Frame
8 weeks
Title
Triglycerides
Time Frame
8 weeks
Title
HDL-cholesterol
Time Frame
8 weeks
Title
Pulse wave velocity
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 25-hydroxyvitamin D levels below 30 ng/ml (75 nmol/L) Arterial hypertension defined according to recent guidelines as an average office blood pressure on at least two occasions of systolic ≥ 140 and/or diastolic ≥ 90 mmHg or a mean 24-hour ABP of systolic ≥ 125 and/or diastolic ≥ 80, or a home blood pressure of systolic ≥ 130 and/or diastolic ≥ 85 or ongoing antihypertensive treatment which was initiated due to arterial hypertension Age of ≥ 18 years Written informed consent. Exclusion Criteria: Hypercalcemia defined a serum calcium >2.65 mmol/L Pregnancy or lactating women Drug intake as part of another clinical study Acute coronary syndrome or cerebrovascular events in the previous 2 weeks Glomerular filtration rate (GFR) according to the MDRD formula < 15 ml/min/1.73m² Systolic 24-hour ABP > 160 mm Hg or < 120 mm Hg Diastolic 24-hour ABP > 100 mm Hg Change of antihypertensive treatment (drugs and/or lifestyle) in the previous 4 weeks or planned changes of antihypertensive treatment during the study Any disease with an estimated life expectancy below 1 year Any clinically significant acute disease requiring drug treatment Chemotherapy or radiation therapy during the study Regular intake of more than 880 International Units (IU) vitamin D per day in the last four weeks before study entry or during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Pilz, MD, PhD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
34629245
Citation
Grubler MR, Zittermann A, Verheyen ND, Trummer C, Theiler-Schwetz V, Keppel MH, Malle O, Richtig G, Gangler S, Bischoff-Ferrari H, Scharnagl H, Meinitzer A, Marz W, Tomaschitz A, Pilz S. Randomized trial of vitamin D versus placebo supplementation on markers of systemic inflammation in hypertensive patients. Nutr Metab Cardiovasc Dis. 2021 Oct 28;31(11):3202-3209. doi: 10.1016/j.numecd.2021.07.028. Epub 2021 Aug 18.
Results Reference
derived
PubMed Identifier
28027911
Citation
Grubler MR, Gaksch M, Kienreich K, Verheyen ND, Schmid J, Mullner C, Richtig G, Scharnagl H, Trummer C, Schwetz V, Meinitzer A, Pieske B, Marz W, Tomaschitz A, Pilz S. Effects of Vitamin D3 on asymmetric- and symmetric dimethylarginine in arterial hypertension. J Steroid Biochem Mol Biol. 2018 Jan;175:157-163. doi: 10.1016/j.jsbmb.2016.12.014. Epub 2016 Dec 24.
Results Reference
derived
PubMed Identifier
27098193
Citation
Grubler MR, Gaksch M, Kienreich K, Verheyen N, Schmid J, O Hartaigh BW, Richtig G, Scharnagl H, Meinitzer A, Pieske B, Fahrleitner-Pammer A, Marz W, Tomaschitz A, Pilz S. Effects of Vitamin D Supplementation on Plasma Aldosterone and Renin-A Randomized Placebo-Controlled Trial. J Clin Hypertens (Greenwich). 2016 Jul;18(7):608-13. doi: 10.1111/jch.12825. Epub 2016 Apr 21.
Results Reference
derived
PubMed Identifier
27006655
Citation
Ernst JB, Tomaschitz A, Grubler MR, Gaksch M, Kienreich K, Verheyen N, Marz W, Pilz S, Zittermann A. Vitamin D Supplementation and Hemoglobin Levels in Hypertensive Patients: A Randomized Controlled Trial. Int J Endocrinol. 2016;2016:6836402. doi: 10.1155/2016/6836402. Epub 2016 Feb 23.
Results Reference
derived
PubMed Identifier
25801871
Citation
Pilz S, Gaksch M, Kienreich K, Grubler M, Verheyen N, Fahrleitner-Pammer A, Treiber G, Drechsler C, O Hartaigh B, Obermayer-Pietsch B, Schwetz V, Aberer F, Mader J, Scharnagl H, Meinitzer A, Lerchbaum E, Dekker JM, Zittermann A, Marz W, Tomaschitz A. Effects of vitamin D on blood pressure and cardiovascular risk factors: a randomized controlled trial. Hypertension. 2015 Jun;65(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.115.05319. Epub 2015 Mar 23.
Results Reference
derived

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Styrian Vitamin D Hypertension Trial

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