The Effects of Oral Vitamin D Supplementation on Cardiovascular Disease Risk in UK South Asian Wome

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 60

Inclusion Criteria

Age = 18 years
Female
Serum 25 hydroxyvitamin D <75nmol/L
South Asian ethnicity, as defined by the participant

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

Symptomatic Cardiovascular Disease (including previous stroke, TIA, angina, myocardial infarction, angioplasty, coronary bypass grafting, symptomatic peripheral vascular disease, chronic heart failure, atrial fibrillation)

Already taking vitamin D supplements. Consumption of fish oils will not be a contraindication to enrolment as the vitamin D content is very low relative to the dose used in the study.

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

Liver function tests (ALT, Bilirubin, Alkaline phosphatase) >3x normal. These two criteria will ensure that sufficient renal and hepatic function is available to convert vitamin D to the active 1,25 hydroxy form.

Unable to give written informed consent

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

Clinical diagnosis of osteomalacia

History of renal calculi, sarcoidosis or metastatic malignancy. Excluding these groups will minimise the risk of side effects from vitamin D supplementation.

Pregnant or of child bearing age and not taking reliable contraception.

Anyone who is pregnant is excluded from taking part in this study. Therefore if the subject is of childbearing potential and there is a possibility that they may be preganant, we will require to catty out a preganancy test beforehand.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: That oral supplementation of vitamin D will improve cardiovascular function and metabolic and inflammatory parameters in South Asian women.<br>;Secondary Objective: Microvascular endothelial function will be tested using Iontophoresis according to standard guidelines<br>Change in arterial stiffness as measured by pulse wave velocity using the validated SphygmoCor pulse waveform analysis system<br>Change in office blood pressure measured by oscillometric automatic blood pressure device<br>Change in metabolic and inflammatory markers:<br><br>;Primary end point(s):

Secondary Outcome Measures

Name	Time	Method

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