Styrian Vitamin D Hypertension Trial

Sponsor

Medical University of Graz (Other)

Overall Status

Completed

CT.gov ID

NCT02136771

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Hypertension Vitamin D Deficiency	Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

24-hour systolic ambulatory blood pressure [8 weeks]

Secondary Outcome Measures

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 [8 weeks]
Plasma renin concentration
Aldosterone [8 weeks]
Plasma aldosterone concentration
24-hour urinary albumin excretion [8 weeks]
HOMA-IR [8 weeks]
HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance)
Triglycerides [8 weeks]
HDL-cholesterol [8 weeks]
Pulse wave velocity [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz		Austria	8036

Sponsors and Collaborators

Medical University of Graz

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT02136771

Other Study ID Numbers:

EudraCT no:2009-018125-70
2009-018125-70

First Posted:

May 13, 2014

Last Update Posted:

Nov 25, 2014

Last Verified:

Nov 1, 2014

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 25, 2014