Clinical trial NCT02136771: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arterial Hypertension
Vitamin D Deficiency
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 24-hour systolic ambulatory blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: 24-hour diastolic ambulatory blood pressure
timeFrame: 8 weeks
measure: N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)
timeFrame: 8 weeks
measure: corrected QT interval (Bazett formula)
timeFrame: 8 weeks
measure: Renin
timeFrame: 8 weeks
measure: Aldosterone
timeFrame: 8 weeks
measure: 24-hour urinary albumin excretion
timeFrame: 8 weeks
measure: HOMA-IR
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: HDL-cholesterol
timeFrame: 8 weeks
measure: Pulse wave velocity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Stefan Pilz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.