The effects of oral vitamin D supplementation on cardiovascular disease risk in UK South Asian wome
- Conditions
- Cardiovascular disease riskCirculatory SystemComplications and ill-defined descriptions of heart disease
- Registration Number
- ISRCTN75081811
- Lead Sponsor
- niversity of Dundee (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 60
1. Aged greater than or equal to 18 years
2. Female
3. Serum 25 hydroxyvitamin D less than 75 nmol/L
4. South Asian ethnicity, as defined by the participant
1. Symptomatic
2. Cardiovascular disease (including previous stroke, transient ischaemic attack [TIA], angina, myocardial infarction, angioplasty, coronary bypass grafting, symptomatic peripheral vascular disease, chronic heart failure, atrial fibrillation)
3. 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.
4. Estimated glomerular filtration rate less than 40 ml/min (by four-variable Modification of Diet in Renal Disease [MDRD] equation)
5. Liver function tests (alanine aminotransferase [ALT], bilirubin, alkaline phosphatase) greater than 3 x 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.
6. Unable to give written informed consent
7. Corrected calcium level of greater than 2.60 or less than 2.15 mmol/L
8. Clinical diagnosis of osteomalacia
9. History of renal calculi, sarcoidosis or metastatic malignancy. Excluding these groups will minimise the risk of side effects from vitamin D supplementation.
10. Pregnant or of childbearing age and not taking reliable contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method