Abstract
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
Highlights
The global prevalence of type 2 diabetes is increasing
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
Non-diabetic hyperglycaemia; either impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) as defined by current World Health Organisation (WHO) criteria [37], or Glycated Haemoglobin (HbA1c) between 5.5% and 6.49%, where this information is available in medical records (London), or in the records of studies in which the participants have consented to being re-approached to consider participating in future studies (Cambridge), or, B
Summary
The global prevalence of type 2 diabetes is increasing. We investigate the effect of vitamin D supplementation on the metabolic status of individuals at increased risk of developing type 2 diabetes. The clinical consequences of type 2 diabetes (T2D) including macrovascular and microvascular disease, and related premature mortality [2] make it a condition of major public health importance. There is convincing evidence that changes to diet and physical activity can help to prevent or delay the onset of T2D among those at high risk [3,4,5,6]. There is accumulating evidence that vitamin D insufficiency is associated with the risk of developing T2D [7,8,9]. Whether supplementation of vitamin D can delay or prevent T2D is unknown
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