Styrian Vitamin D Hypertension Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Arterial Hypertension
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Vitamin D3

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin D3; 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	Dietary supplement: Vitamin D3; 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
Placebo Comparator: Placebo; Oily drops as placebo	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24-hour systolic ambulatory blood pressure	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour diastolic ambulatory blood pressure		8 weeks
N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)		8 weeks
corrected QT interval (Bazett formula)		8 weeks
Renin	Plasma renin concentration	8 weeks
Aldosterone	Plasma aldosterone concentration	8 weeks
24-hour urinary albumin excretion		8 weeks
HOMA-IR	HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance)	8 weeks
Triglycerides		8 weeks
HDL-cholesterol		8 weeks
Pulse wave velocity		8 weeks

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Stefan Pilz, MD, PhD, Medical University of Graz

Publications and helpful links

General Publications

• Grübler MR, Zittermann A, Verheyen ND, Trummer C, Theiler-Schwetz V, Keppel MH, Malle O, Richtig G, Gängler S, Bischoff-Ferrari H, Scharnagl H, Meinitzer A, März 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 9, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): November 25, 2014
• Last Update Submitted That Met QC Criteria: November 23, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Hypertension; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: EudraCT no:2009-018125-70; 2009-018125-70 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No