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      Effect of vitamin D supplementation on health status in non-vitamin D deficient people with type 2 diabetes mellitus

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          Abstract

          Objective

          Increased levels of depressive symptoms, fatigue or pain (all dimensions of reduced health-related quality of life (HRQOL)) are common in people with type 2 diabetes mellitus (DM). Earlier studies have reported associations between low vitamin D status and fatigue and depressive symptoms. The aim of the present study was to examine the effects of vitamin D supplementation on dimensions of HRQOL in people with type 2 DM.

          Design

          Randomised, double-blind, placebo-controlled trial.

          Methods

          The effect of monthly cholecalciferol 50,000 IU vs placebo on HRQOL was assessed in 275 adults with type 2 DM derived from general practices. HRQOL at baseline and after six months using the Short Form 36 Health Survey (SF-36) was collected. Linear regression analyses were used to compare the change in HRQOL over time between the vitamin D and placebo group.

          Results

          187/275 (68%) completed baseline and follow-up SF-36 and were included in the analysis. Median serum 25-hydroxyvitamin D almost doubled in the intervention group compared to that in the placebo group (58.5–106.0 nmol/L vs 60.0–61.5 nmol/L, respectively). A small significant difference (adjusted B: −8.90; 95% CI: −17.16 to −0.65) between both groups was seen concerning the SF-36 domain role limitations due to physical problems in disadvantage of the vitamin D group.

          Conclusions

          Six months of vitamin D supplementation did not improve HRQOL in non-vitamin D-deficient people with type 2 DM managed on oral antidiabetic therapy.

          Related collections

          Most cited references19

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          Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomised Evaluation of Calcium Or vitamin D, RECORD): a randomised placebo-controlled trial.

          Elderly people who have a fracture are at high risk of another. Vitamin D and calcium supplements are often recommended for fracture prevention. We aimed to assess whether vitamin D3 and calcium, either alone or in combination, were effective in prevention of secondary fractures. In a factorial-design trial, 5292 people aged 70 years or older (4481 [85%] of whom were women) who were mobile before developing a low-trauma fracture were randomly assigned 800 IU daily oral vitamin D3, 1000 mg calcium, oral vitamin D3 (800 IU per day) combined with calcium (1000 mg per day), or placebo. Participants who were recruited in 21 UK hospitals were followed up for between 24 months and 62 months. Analysis was by intention-to-treat and the primary outcome was new low-energy fractures. 698 (13%) of 5292 participants had a new low-trauma fracture, 183 (26%) of which were of the hip. The incidence of new, low-trauma fractures did not differ significantly between participants allocated calcium and those who were not (331 [12.6%] of 2617 vs 367 [13.7%] of 2675; hazard ratio (HR) 0.94 [95% CI 0.81-1.09]); between participants allocated vitamin D3 and those who were not (353 [13.3%] of 2649 vs 345 [13.1%] of 2643; 1.02 [0.88-1.19]); or between those allocated combination treatment and those assigned placebo (165 [12.6%] of 1306 vs 179 [13.4%] of 1332; HR for interaction term 1.01 [0.75-1.36]). The groups did not differ in the incidence of all-new fractures, fractures confirmed by radiography, hip fractures, death, number of falls, or quality of life. By 24 months, 2886 (54.5%) of 5292 were still taking tablets, 451 (8.5%) had died, 58 (1.1%) had withdrawn, and 1897 (35.8%) had stopped taking tablets but were still providing data for at least the main outcomes. Compliance with tablets containing calcium was significantly lower (difference: 9.4% [95% CI 6.6-12.2]), partly because of gastrointestinal symptoms. However, potentially serious adverse events were rare and did not differ between groups. The findings do not support routine oral supplementation with calcium and vitamin D3, either alone or in combination, for the prevention of further fractures in previously mobile elderly people.
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            Painful diabetic polyneuropathy: epidemiology, pain description, and quality of life.

            A prospective survey study was performed in patients with painful diabetic polyneuropathy (PDN) to assess the nature and scope of their pain. Pain associated with diabetic neuropathy is commonly encountered in clinical practice. Yet, little is known regarding the pain experience and impact on quality of life in persons with painful diabetic neuropathy. These 105 patients noted an average of 6/10 pain, most often described as 'burning', 'electric', 'sharp', and 'dull/ache', which, for most, is worse at night time and when tired or stressed. On average, patients reported that the pain caused substantial interference in sleep and enjoyment of life and moderate interference in recreational activities, normal work, mobility, general activity, social activities, and mood. Unexpectedly, a potential genetic predisposition to the development of painful neuropathy was suggested by the fact that a majority (56%) reported a family member with PDN. Thus, this study found that pain associated with diabetic neuropathy is a significant medical issue that has a substantial impact on the quality of life of many people with this condition.
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              Effect of vitamin D supplementation on glycaemic control and insulin resistance: a systematic review and meta-analysis.

              To systematically review the evidence for the effect of vitamin D supplementation on glycaemia, insulin resistance, progression to diabetes and complications of diabetes. Systematic review and meta-analysis. We searched databases including MEDLINE, EMBASE and the Cochrane Library for randomized controlled trials comparing vitamin D or analogues with placebo. We extracted data on fasting glucose, glycaemic control, insulin resistance, insulin/C-peptide levels, micro- and macrovascular outcomes and progression from non-diabetes to diabetes. Studies were assessed independently by two reviewers according to a pre-specified protocol. Fifteen trials were included in the systematic review. Trial reporting was of moderate, variable quality. Combining all studies, no significant improvement was seen in fasting glucose, HbA(1c) or insulin resistance in those treated with vitamin D compared with placebo. For patients with diabetes or impaired glucose tolerance, meta-analysis showed a small effect on fasting glucose (-0.32 mmol/l, 95%CI -0.57 to -0.07) and a small improvement in insulin resistance (standard mean difference -0.25, 95%CI -0.48 to -0.03). No effect was seen on glycated haemoglobin in patients with diabetes and no differences were seen for any outcome in patients with normal fasting glucose. Insufficient data were available to draw conclusions regarding micro- or macrovascular events; two trials failed to show a reduction in new cases of diabetes in patients treated with vitamin D. There is currently insufficient evidence of beneficial effect to recommend vitamin D supplementation as a means of improving glycaemia or insulin resistance in patients with diabetes, normal fasting glucose or impaired glucose tolerance. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

                Author and article information

                Journal
                Endocr Connect
                Endocr Connect
                EC
                Endocrine Connections
                Bioscientifica Ltd (Bristol )
                2049-3614
                November 2016
                16 November 2016
                : 5
                : 6
                : 61-69
                Affiliations
                [1 ]Department of Internal Medicine Medical Centre Alkmaar, Alkmaar, the Netherlands
                [2 ]Department of General Practice DIAZON, Alkmaar, the Netherlands
                [3 ]Department of Epidemiology and Biostatistics VU Medical Centre, Amsterdam, the Netherlands
                [4 ]Department of Internal Medicine Endocrine Section, VU Medical Centre, Amsterdam, the Netherlands
                [5 ]Department of Medical and Clinical Psychology Tilburg University, Tilburg, the Netherlands
                Author notes
                Correspondence should be addressed to S Simsek; Email: s.simsek@ 123456mca.nl
                Article
                EC160070
                10.1530/EC-16-0070
                5118972
                27803154
                0142a391-c414-40ad-899a-1f6ef9fbda3a
                © 2016 The authors

                This work is licensed under a Creative Commons Attribution 4.0 International License.

                History
                : 14 October 2016
                : 1 November 2016
                Categories
                Research

                rct,vitamin d,health-related quality of life,type 2 diabetes mellitus

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