Effect of vitamin D supplementation on inflammatory markers in non-obese lebanese patients with type 2 diabetes: A randomized controlled trial

Abstract

Background: A low serum 25-hydroxyvitamin D (25(OH) D) concentration has been associated with a higher risk of type 2 diabetes mellitus (T2DM), especially in older people. Our aim in this randomized controlled trial was to evaluate the effect of vitamin D treatment on inflammatory markers in non-obese Lebanese patients with T2DM, living in Beirut, Lebanon. Methods: Non-Obese patients with T2DM (n = 88), deficient/insufficient in vitamin D, were randomly assigned into one of two groups—a treatment group receiving 30,000 IU cholecalciferol/week for a period of six months, and a placebo group. Serum concentrations of TNF-α, high-sensitivity C-reactive protein (hs-CRP), and Interleukin-6 (IL-6) were the primary outcomes. A homeostatic model of insulin resistance (HOMA-IR) was assessed, in addition to serum concentrations of fasting blood glucose (FBG), HbA1C, (25(OH) D), and PTH. Results: The vitamin D group showed higher blood levels of (25(OH) D) (p < 0.0001), and a significant reduction in hs-CRP and TNF-α concentrations (p < 0.0001) compared to placebo. The decrease perceived in IL-6 concentrations was not significant (p = 0.1). No significant changes were seen in FBG (p = 0.9) and HbA1c levels (p = 0.85). Conclusion: Six months of vitamin D supplementation led to a decrease in some inflammatory markers in patients with T2DM. Additional studies with a larger sample and a longer period are advised in this regard. This trial was registered at ClinicalTrial.gov; Identifier number: NCT 03782805.