EUCTR2008-003387-18-GB进行中（未招募）不适用
The Effects of Oral Vitamin D Supplementation on Cardiovascular Disease Risk in UK South Asian Women
niversity of Dundee0 个研究点目标入组 60 人开始时间: 2008年11月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Age = 18 years
- •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
排除标准
- •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.
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