Effects of vitamin D supplementation on markers of vascular function after myocardial infarction: a placebo controlled, double blind, parallel group, randomised controlled trial

niversity of Dundee (UK)0 个研究点目标入组 80 人开始时间: 2009年1月30日最近更新: 2018年3月19日

适应症

试验速览

•1. Confirmed diagnosis of myocardial infarction, based on the recently published Universal criteria for diagnosis of myocardial infarction: Troponin T greater than 0.02 plus one of the following:
•1.1. Symptoms consistent with myocardial ischaemia
•1.2. Electrocardiogram (ECG) changes consistent with myocardial ischaemia
•1.3. New Q waves on ECG
•1.4. New regional wall motion abnormality or evidence of new loss of viable myocardium on imaging
•2. Admitted to Tayside Hospitals within 1 week of index event
•3. Aged greater than 18 years, either sex
•4. Minimum of 6 weeks after index event (to allow for medication stabilisation and percutaneous/surgical interventions)

•1. Estimated glomerular filtration rate (GFR) less than 40 ml/min (using the MDRD4 method)
•2. Adjusted serum calcium less than 2.15 mmol/L or greater than 2.60 mmol/L
•3. Liver function tests (LFTs) greater than 3 x upper limit of normal
•4. 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.
•5. Known metastatic malignancy
•6. History of renal calculi or sarcoidosis
•7. Supine systolic blood pressure (BP) less than 80 mmHg
•8. Pregnant, lactating, or of childbearing age and not taking reliable contraception
•9. Unable to give written informed consent

发起方

niversity of Dundee (UK)