This study was conducted to examine the effects of vitamin D, K and Ca co-supplementation on carotid intima-media thickness (CIMT) and metabolic status in overweight diabetic patients with CHD. This randomised, double-blind, placebo-controlled trial was conducted among sixty-six diabetic patients with CHD. Participants were randomly allocated into two groups to take either 5 µg vitamin D, 90 µg vitamin K plus 500 mg Ca supplements (n 33) or placebo (n 33) twice a day for 12 weeks. Fasting blood samples were obtained at the beginning of the study and after the 12-week intervention period to determine related markers. Vitamin D, K and Ca co-supplementation resulted in a significant reduction in maximum levels of left CIMT (−0·04 (SD 0·22) v. +0·04 (SD 0·09) mm, P = 0·02). Changes in serum vitamin D (+6·5 (SD 7·8) v. +0·4 (SD 2·2) ng/ml, P < 0·001), Ca (+0·6 (SD 0·3) v. +0·1 (SD 0·1) mg/dl, P < 0·001) and insulin concentrations (−0·9 (SD 3·1) v. +2·6 (SD 7·2) µIU/ml, P = 0·01), homoeostasis model for assessment of estimated insulin resistance (−0·4 (SD 1·2) v. +0·7 (SD 2·3), P = 0·01), β-cell function (−2·1 (SD 9·0) v. +8·9 (SD 23·7), P = 0·01) and quantitative insulin sensitivity check index (+0·007 (SD 0·01) v. −0·006 (SD 0·02), P = 0·01) in supplemented patients were significantly different from those in patients in the placebo group. Supplementation resulted in significant changes in HDL-cholesterol (+2·7 (SD 7·0) v. −2·5 (SD 5·7) mg/dl, P = 0·002), high-sensitivity C-reactive protein (−1320·1 (SD 3758·3) v. +464·0 (SD 3053·3) ng/ml, P = 0·03) and plasma malondialdehyde concentrations (−0·4 (SD 0·5) v. −1·0 (SD 1·1) µmol/l, P = 0·007) compared with placebo. Overall, vitamin D, K and Ca co-supplementation for 12 weeks among diabetic patients with CHD had beneficial effects on maximum levels of left CIMT and metabolic status. The effect of vitamin D, K and Ca co-supplementation on maximum levels of left CIMT could be a chance finding.
The Editor-in-Chief has been alerted to concerns about the integrity of the above article and is investigating the claims. The concerns have also been referred to the Iranian National Committee for Ethics in Biomedical Research. This statement will be updated when both investigations have been completed and the authors have been given the opportunity to respond to the outcomes of those investigations.
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