The effects of oral vitamin D supplementation on cardiovascular disease risk in UK South Asian women: a randomised, placebo-controlled, parallel-group, double-blinded study

niversity of Dundee (UK)0 个研究点目标入组 60 人开始时间: 2008年9月4日最近更新: 2017年12月18日

试验速览

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•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

发起方

niversity of Dundee (UK)