DOES VITAMIN D REDUCE BLOOD PRESSURE AND LV MASS IN RESISTANT HYPERTENSIVE PATIENTS WITH VITAMIN D INSUFFICIENCY? - Vitamin D for resistant hypertensio

Phase 1

Conditions: Resistant Hypertension
MedDRA version: 9.1Level: LLTClassification code 10020783Term: Hypertension not adequately controlled

Registration Number: EUCTR2008-002681-63-GB

Lead Sponsor: Research and Innovation Services, University of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 74

Inclusion Criteria

Age >18 yrs
Office BP >140/90 mmHg despite 3 or more antihypertensive agents
Serum 25 Hydroxy vitamin D <75nmol/L

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

Hypertension known to be due to a correctable underlying medical or surgical cause

Estimated glomerular filtration rate <40mls/min (by 4 variable MDRD equation)

Liver function tests (ALT, Bilirubin, Alkaline phosphatase) >3x normal.

Corrected calcium >2.60 mmol/L or <2.15 mmol/L

Known metastatic malignancy or sarcoidosis

Clinical diagnosis of osteomalacia

History of renal calculi

Diagnosis of heart failure with left ventricular systolic dysfunction

Atrial fibrillation

Already taking vitamin D supplements (cod liver oil will be permitted however)

Unable to give written informed consent

Premenopausal / able to bear children (if female)

Contraindications to MRI scanning (severe claustrophobia, pacemaker, metal heart valve, metal in eye, ferromagenetic joint implants or spinal rods, implanted nerve stimulator, middle ear implant)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test whether high dose vitamin D3 can improve blood pressure in patients with resistant hypertension (i.e. hypertension not adequately controlled by three antihypertensive agents);Secondary Objective: To test whether high dose vitamin D3 can cause regression of left ventricular hypertrophy in patients with resistant hypertension;Primary end point(s): Change in mean 24 hour systolic blood pressure at 6 months

Secondary Outcome Measures