补充维生素D₂或D₃对2型糖尿病高危人群血糖控制及相关代谢参数的影响：一项随机双盲安慰剂对照试验方案
The effects of vitamin D₂ or D₃ supplementation on glycaemic control and related metabolic parameters in people at risk of type 2 diabetes: protocol of a randomised double-blind placebo-controlled trial.
作者信息
Menon Ravi K, Rickard Anna P, Mannan Nasima, Timms Peter M, Sharp Stephen J, Martineau Adrian, Boucher Barbara J, Chowdhury Tahseen A, Griffiths Christopher J, Griffin Simon J, Hitman Graham A, Forouhi Nita G
机构信息
Blizard Institute, Queen Mary University of London, London, UK.
出版信息
BMC Public Health. 2013 Oct 23;13:999. doi: 10.1186/1471-2458-13-999.
BACKGROUND
The global prevalence of type 2 diabetes is increasing. Effective strategies to address this public health challenge are currently lacking. A number of epidemiological studies have reported associations between low concentrations of 25-hydroxy vitamin D and the incidence of diabetes, but a causal link has not been established. We investigate the effect of vitamin D supplementation on the metabolic status of individuals at increased risk of developing type 2 diabetes.
METHODS/DESIGN: In a randomised double-blind placebo-controlled trial individuals identified as having a high risk of type 2 diabetes (non-diabetic hyperglycaemia or positive diabetes risk score) are randomised into one of three groups and given 4 doses of either placebo, or 100,000 IU Vitamin D₂ (ergocalciferol) or 100,000 IU Vitamin D₃ (cholecalciferol) at monthly intervals. The primary outcome measure is the change in glycated haemoglobin level between baseline and 4 months. Secondary outcome measures include blood pressure, lipid levels, apolipoproteins, highly sensitive C-reactive protein, parathyroid hormone (PTH) and safety of supplementation. and C-reactive protein. The trial is being conducted at two sites (London and Cambridge, U.K.) and a total of 342 participants are being recruited.
DISCUSSION
Trial data examining whether supplementation of vitamin D improves glycaemic status and other metabolic parameters in people at risk of developing type 2 diabetes are sparse. This trial will evaluate the causal role of vitamin D in hyperglycaemia and risk of type 2 diabetes. Specific features of this trial include recruitment of participants from different ethnic groups, investigation of the relative effectiveness and safety of vitamin D₂ and D₃ and an evidence based approach to determination of the dose of supplementation.
TRIAL REGISTRATION
EudraCT2009-011264-11; ISRCTN86515510.
背景
2型糖尿病在全球的患病率正在上升。目前缺乏应对这一公共卫生挑战的有效策略。多项流行病学研究报告了低浓度25-羟基维生素D与糖尿病发病率之间的关联，但尚未确立因果关系。我们研究补充维生素D对2型糖尿病发病风险增加个体代谢状况的影响。
方法/设计：在一项随机双盲安慰剂对照试验中，被确定为2型糖尿病高危人群（非糖尿病性高血糖或糖尿病风险评分阳性）被随机分为三组之一，每月间隔给予4剂安慰剂、100,000 IU维生素D₂（麦角钙化醇）或100,000 IU维生素D₃（胆钙化醇）。主要结局指标是基线至4个月期间糖化血红蛋白水平的变化。次要结局指标包括血压、血脂水平、载脂蛋白、高敏C反应蛋白、甲状旁腺激素（PTH）以及补充剂的安全性和C反应蛋白。该试验在两个地点（英国伦敦和剑桥）进行，共招募342名参与者。
讨论
关于补充维生素D是否能改善2型糖尿病发病风险人群的血糖状况和其他代谢参数的试验数据很少。该试验将评估维生素D在高血糖和2型糖尿病风险中的因果作用。该试验的具体特点包括从不同种族群体招募参与者、研究维生素D₂和D₃的相对有效性和安全性以及采用基于证据的方法确定补充剂剂量。
试验注册
EudraCT2009-011264-11；ISRCTN86515510。
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