Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).

Vitamin D deficiency may contribute to etiology of type 2 diabetes in Asian Indians. The objectives of this study was to evaluate effect of vitamin D supplementation on glycemic profile and body composition in prediabetic and vitamin D deficient overweight/obese Asian Indian women. In this open-label randomized placebo-controlled trial (78 weeks duration), 121 females (aged 20-60 years) with prediabetes and vitamin D deficiency were randomly allocated in intervention (n, 61) and placebo (n, 60) groups. The primary outcome variables were fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia. In Intention-to-treat analysis, at the end of intervention, we observed significant decrease in FBG [-5.0 (-12.6-2.4), p = 0.04], 2-h blood glucose post OGTT [-11(-49.3-26.9), p = 0.02], hemoglobin A1c [-0.41 (5.89, 6.55), p = 0.05] and increase in 25(OH) D [7.5 (-6.0-20.9), p = 0.002] levels in intervention as compared to the placebo group. Changes in glycemic category based on FBG were as follows; intervention group: normal FBG, 58.6%; impaired fasting glucose (IFG), 39%; and type 2 diabetes mellitus (T2DM), 2.4%; placebo group: normal FBG, 48.8%; IFG, 46.3%; and T2DM, 4.9%. Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%. After intervention, subscapular skinfold (visit I ^st compared to visit III ^rd ) and suprailiac skinfold (visit II ^nd compared to visit III ^rd ) were significantly lower in intervention group vs. control group. In conclusion, we observed significant reduction in FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia in overweight/obese prediabetic vitamin D deficient Asian Indian women after 78 weeks of vitamin D supplementation.