Arterial Hypertension, Vitamin D Deficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin 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_SUPPLEMENTPlacebo
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour systolic ambulatory blood pressure | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 diastolic ambulatory blood pressure | 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 | — |
| 24-hour urinary albumin excretion | 8 weeks | — |
Countries
Austria
Outcome results
None listed