Aims: 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).
Methods: 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 (300,000 IU, 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 8 weeks.
Results: 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 ± 19.2 ng/mL) and those of FBS and HbA1c decreased significantly [186.5 ± 64.1 vs. 165.1 ± 58.5 mg/dL and 8.2 ± 2.0 % (66.3 ± 21.8 mmol/mol) vs. 7.7 ± 1.8 % (61.7 ± 20.0 mmol/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.
Conclusions: A single parenteral dose of vitamin D in T2D patients with IHD improved glycemic control, but not inflammatory status.
Clinical trial registry: Australian New Zealand Clinical Trial Registry.
Clinical trial number: ACTRN12614000529640.
Keywords: Diabetes; Glycemic status; Ischemic heart disease; Vitamin D.