The effect of a single dose of vitamin D on glycemic status and C-reactive protein levels in type 2 diabetic patients with ischemic heart disease: a randomized clinical trial.

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To assess whether a single parental dose of 25-hydroxy vitamin D [25(OH)Vit D] could improve glucose control and inflammation in type 2 diabetic patients (T2D) with ischemic heart disease (IHD). A randomized, placebo-controlled, double-blind trial was performed on 95 patients (47-placebo and 48-vitamin D groups). Participants were randomized using a randomization table to a single dose of either vitamin D (300,000IU, IM) or a matching placebo. Fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), 25(OH)Vit D and high-sensitivity C-reactive protein (hs-CRP) were measured at baseline and at 8weeks. No significant differences in baseline values were noted between groups, except in HbA1c, which was lower in the placebo group. In the supplemented group, the level of serum 25(OH)Vit D increased (29.6±20.8 vs. 44.5±19.2ng/mL) and those of FBS and HbA1c decreased significantly [186.5±64.1 vs. 165.1±58.5mg/dL and 8.2±2.0% (66.3±21.8mmol/mol) vs. 7.7±1.8% (61.7±20.0mmol/mol), respectively] (all p<0.05), and no changes, however, were observed in the placebo group. We also compared change of marginal means of outcome variables (HbA1c, FBS, 25(OH)Vit D and hs-CRP) from baseline between the vitamin D versus placebo group, using ANCOVA, adjusted for the baseline of each variable itself, season at study entry, age and body mass index. During trial, only HbA1c level decreased significantly [0.48% (standard error: 0.17), p=0.04]. No any adverse effect was seen. A single parenteral dose of vitamin D in T2D patients with IHD improved glycemic control, but not inflammatory status. Australian New Zealand Clinical Trial Registry. ACTRN12614000529640.