TO DETERMINE IF PHARMACOLOGICAL TREATMENT OF LOW VITAMIN D CONCENTRATION MAY REDUCE HEART, RENAL AND VASCULAR DAMAGE IN PATIENTS WITH HIGH BLOOD PRESSURE LEVELS

Conditions: HYPERTENSION AND HYPOVITAMINOSIS D
MedDRA version: 14.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-003514-14-IT

Lead Sponsor: IVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients of both sexes with essential hypertension, systolic and diastolic blood pressure lower than 140 mmHg and 90 mmHg respectively during stable drug's treatment, and serum levels of 25OHD3 lower than 20 ng/ml
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Age <35 yrs. or >75 yrs. - Body Mass Index <20 Kg/m2 or >35 Kg/m2 - Secondary hypertension - Personal and/or family history of rickets and osteomalacia - Serum levels of total calcium and/or intact PTH beyond the upper limit of laboratory reference range - Primary or secondary hyperparathiroidism - Fasting blood glucose >126 mg/dL. - Glomerular filtrate ratio <60 ml/min/1,73 m2 - Renal tubular acidosis - TSH serum levels <0.5 mUI/ml or >4.5 mUI/ml - Alteration in nutritional status - Personal history positive for sarcoidosis, type I and II diabetes mellitus, nephrolithiasis, atrial fibrillation, atrial flutter, atrial or ventricular extrasystoles Lown class II or higher. - Electrocardiographic evidence of non-normal sinus rhythm or atrial/ventricular extrasystoles. - Positive history for assumption of antiarrhythmic agents, digoxin, warfarin, anticonvulsant or barbituric drugs, systemic glucocorticoids, antacid drugs containing aluminum, magnesium, cholestiramine or colestipol, orlistat, rifampicin, antiresorptive drugs, vitamin D.