No effect of vitamin D supplementation on cardiovascular risk factors in subjects with metabolic syndrome: a pilot randomised study.

Introduction: Patients with metabolic syndrome (MetS) may have lower 25-hydroxyvitamin D (25(OH)VitD) serum levels compared with non-MetS individuals. Vitamin D (VitD) deficiency is associated with various cardiovascular disease (CVD) risk factors. Yet, the effect of VitD supplementation on MetS remains uncertain. Our aim was to examine the effect of VitD supplementation on CVD risk factors in MetS subjects.

Material and methods: This pilot study had a PROBE (prospective, randomised, open-label, blinded end-point) design. Fifty patients with MetS were included and randomised either to dietary instructions ( n = 25) (control group) or dietary instructions plus VitD 2000 IU/day ( n = 25) (VitD group) for 3 months. This study is registered in ClinicalTrials.gov (NCT01237769).

Results: In both groups a similar small weight reduction was achieved. In the VitD group serum 25(OH)VitD levels significantly increased by 91% (from 16.0 (3.0-35.0) to 30.6 (8.4-67.0) ng/ml, p < 0.001), while in the control group no significant change was observed (from 10.0 (4.0-39.6) to 13.0 (3.5-37.0) ng/ml). In both groups triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, fasting glucose, haemoglobin A1c , homeostasis model assessment index and diastolic blood pressure did not significantly change. Systolic blood pressure decreased by 3.7% (from 134 ±14 to 129 ±13 mm Hg, p = 0.05) in the VitD group, while it decreased by 1.5% (from 132 ±13 to 130 ±16 mm Hg, p = NS) in the control group ( p = NS between groups). In the VitD group serum 25(OH)VitD increase was negatively correlated with SBP decrease ( r = -0.398, p = 0.049).

Conclusions: VitD supplementation (2000 IU/day) did not affect various CVD risk factors in patients with MetS.