• Ravi K Menon, Anna P Rickard, Nasima Mannan, Peter M Timms, Stephen J Sharp, Adrian Martineau, Barbara J Boucher, Tahseen A Chowdhury, Christopher J Griffiths, Simon J Griffin, Graham A Hitman, and Nita G Forouhi.
• Blizard Institute, Queen Mary University of London, London, UK. g.a.hitman@qmul.ac.uk.
• Bmc Public Health. 2013 Jan 1;13:999.

BackgroundThe 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/DesignIn 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.DiscussionTrial 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 RegistrationEudraCT2009-011264-11; ISRCTN86515510.

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