Can high-dose vitamin D supplementation reduce blood pressure and markers of cardiovascular risk in older people with isolated systolic hypertension? - Vitamin D in ISH

Phase 1

Conditions: Isolated systolic hypertension
MedDRA version: 9.1Level: LLTClassification code 10050591Term: Isolated systolic hypertension

Registration Number: EUCTR2008-004534-24-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

Age > or = 70 yrs
Office systolic BP > or = 140 mmHg
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) no
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

Diastolic blood pressure >90mmHg

Systolic blood pressure >180mmHg

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. Consumption of fish oils will not be a contraindication to enrolment

Unable to give written informed consent

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 aged 70 and over with isolated systolic hypertension;Secondary Objective: To test whether high dose vitamin D3 can improve markers of vascular health including endothelial function, arterial stiffness and b-type natriuretic peptide in patients aged 70 and over with isolated systolic hypertension;Primary end point(s): Change in office blood pressure at 3 months

Secondary Outcome Measures