Patients with arterial hypertension and vitamin D deficiency
Conditions
Interventions
Trade Name: OLEOVIT D3-Tropfen
Product Name: OLEOVIT D3-Tropfen
Product Code: 10.898
Pharmaceutical Form: Oral drops*
INN or Proposed INN: Vitamin D3 (colecalciferol)
Concentration number: 12000 IU-pe
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age of at least 18 years 25(OH)D levels below 30 ng/ml Arterial hypertension Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hypercalcemia (serum calcium above 2.65 mmol/l) Pregnancy and lactating women Intake of medications as part of another clinical trial during the study period Acute coronary syndrome or previous cerebrovascular event within the last two weeks GFR < 15 ml/min/1.73m² Mean 24 hours ambulatory blood pressure of systolic above 160 mm Hg and/or below 120 mm Hg, and/or diastolic blood pressure above 100 mm Hg Chnage of antihypertensive treatment (drugs and/or lifestyle) within the last four weeks or planned change of antihypertensive treatment within the study period Life expectancy of below 1 year Any clinically significant acute illness which requires drug treatment Ongoing chemotherapy of radiotherapy during the trial Regular intake of over 880 international units of vitamin D per day within the last four weeks before study entry and/or during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate in a randomized, double-blind, placeblo controlled trial whether vitamin D supplementation significantly alters mean diastolic ambulatory blood pressure, N-terminal pro-brain natriuretic peptide (NT-pro-BNP), QT time, direct renin concentration, aldosterone, 24 hours urinary albumin excretion, HOMA (homeostasis model assessment) Index, triglycerides and HDL-cholsterol.;Primary end point(s): Mean systolic 24 hours ambulatory blood pressure;Main Objective: To evaluate in a randomized, double-blind, placebo controlled trial whether vitamin D supplementation significantly alters mean systolic ambulatory blood pressure | — |
Countries
Austria
Outcome results
None listed