Styrian Vitamin D Hypertension Trial

Vitamin D Deficiency Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136771
• Other study ID #: EudraCT no:2009-018125-70
• Secondary ID: 2009-018125-70
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2014
• Last updated: November 23, 2014
• Start date: June 2011
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour systolic ambulatory blood pressure		8 weeks	No
Secondary	24-hour diastolic ambulatory blood pressure		8 weeks	No
Secondary	N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)		8 weeks	No
Secondary	corrected QT interval (Bazett formula)		8 weeks	No
Secondary	Renin	Plasma renin concentration	8 weeks	No
Secondary	Aldosterone	Plasma aldosterone concentration	8 weeks	No
Secondary	24-hour urinary albumin excretion		8 weeks	No
Secondary	HOMA-IR	HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance)	8 weeks	No
Secondary	Triglycerides		8 weeks	No
Secondary	HDL-cholesterol		8 weeks	No
Secondary	Pulse wave velocity		8 weeks	No