HYPERTENSION AND HYPOVITAMINOSIS D MedDRA version: 14.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: DIBASE*OS SOLUZ 2,5ML 25000UI
Pharmaceutical Form: Oral solution
INN or Proposed INN: COLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: VITAMINA D
Concentration unit: mg milligram(s
Sponsors
UNIVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Age 75 yrs. - Body Mass Index 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of cholecalciferol supplementation on blood pressure control and clinical and subclinical organ damage in patients with essential hypertension, stable drug therapy, and documented vitamin D deficiency;Secondary Objective: To evaluate the influence of vitamin D receptor (VDR) allelic variants on pharmacological response to oral cholecalciferol therapy;Primary end point(s): - Comparative evaluation between the two groups of overall drugs consumption for maintenance of blood pressure control during the study - A composite endopoint linked to the evaluation of organ damage(considered reached after achieving at least one secondary endpoint);Timepoint(s) of evaluation of this end point: Twelve-months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Left ventricular massreduction =7 g/m2.7 - Pulse wave velocity reduction = 0.9 m/s - Albuminuria reduction = 45 mg/24h - Reduction in circulating levels of atrial natriuretic peptide =600 fmol/ml;Timepoint(s) of evaluation of this end point: Twelve months | — |
Countries
Italy
Contacts
Public ContactDipartimento di Medicina Clinica e
Università degli Studi di Napoli ''Federico II''
Outcome results
None listed