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

BMC Public Health

Nita G Forouhi¹  Graham A Hitman³  Simon J Griffin¹  Christopher J Griffiths⁶  Tahseen A Chowdhury⁵  Barbara J Boucher⁴  Adrian Martineau⁶  Stephen J Sharp¹  Peter M Timms²  Nasima Mannan⁴  Anna P Rickard¹  Ravi K Menon⁴ 

[1] Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK;Homerton University Hospital NHS Foundation Trust, London, UK;Blizard Institute, Barts and The London School of Medicine and Dentistry, 4 Newark Street, London E1 2AT, UK;Blizard Institute, Queen Mary University of London, London, UK;Barts Healthcare NHS Trust, London, UK;Centre for Health Sciences, Queen Mary University of London, London, UK

关键词: Intervention;    Trial;    Randomised;    Type 2 diabetes;    Placebo;    Vitamin D₃;    Vitamin D₂;   

Others  :  1161623
DOI  :  10.1186/1471-2458-13-999

 received in 2012-11-29, accepted in 2013-10-14,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Menon et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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